I-15 ephezulu Msumari wa ndani ya mfupa abavelisi eSpain (2026 Isikhokelo sokuThenga izinto)

Intshayelelo

Indawo yokuthengwa kwezixhobo zonyango kwicandelo lamathambo eSpain ifumana inguqu ekhawulezileyo yolwakhiwo. Iqhutywe yimimiselo engqongqo yokugcinwa kweendleko ezivela kwi-Ofisi yoMphathiswa wezeMpilo ( Ministerio de Sanidad ) kunye ne-decentralized high trauma volumes elawulwa ziinkonzo zempilo yoluntu ezizimeleyo ( Servicios de Salud Autonómicos ) -njenge-SERMAS (Madrid), SAS ( Andalucía ), Catsalut ( Cataluña ), kunye ne-SACYL Quirón , kunye nesibhedlele sabucala se-SACYL (Cataluñasti) kunye ne-SACYL Leónsti kunye ne-Vithas-iibhodi zokuthengwa kwesibhedlele zibeka phambili ukufakelwa kwezinto ezibonelela ngolungelelwaniso olufanelekileyo lwezonyango, ukhuseleko lolawulo, kunye nokuqikelelwa kohlahlo lwabiwo-mali.

Xa ulawula ukuphuka kwamathambo amade, ukukhetha i-intramedullary (IM) iqabane elifanelekileyo lesikhonkwane kubalulekile ekunciphiseni iingxaki emva kokusebenza kunye nokulawula iindleko zeziko phantsi kwesakhelo seLicitaciones Públicas (IiTenda zoLuntu). Esi sikhokelo sichaza i-Top 15 Msumari wa ndani ya mfupa Abavelisi baseSpain, begxininise kwiipotfoliyo zabo eziphambili, udumo lwemarike, kunye neteknoloji engundoqo yokuncedisa iinjineli ze-biomedical, oogqirha bamathambo, kunye nabaphathi bokubonelela ekwenzeni izigqibo eziqhutywa yidatha.

Ukwandiswa kobuGcisa: Ukuqonda okuKhethekileyo Msumari wa ndani ya mfupa uYilo kwiNgxowa-mali yeNtuthuko yanamhlanje

Kuvandlakanyo olubanzi lwethenda yezonyango kuzo zonke iindawo ezikhokelayo zokhathalelo lwempilo, ukuthengwa kwe-orthopedic trauma kufuna ukuqonda okunzulu kobugcisa bokufakelwa koomatshini. Izikhonkwane ze-Intramedullary azisekho iintsimbi zentsimbi; utyando lwangoku lufuna uyilo olukhethekileyo lwebhayomechanical olulungelelaniswe nokwakheka koqhekeko oluthile kunye nezifo zesigulana.

Ukunceda iibhodi zezibhedlele kunye neekomiti zotyando zilungelelanise ukufunyanwa komonzakalo, kubalulekile ukuqonda iindidi eziphambili ze Misumari ya ndani ya mfupa ezilawula iithiyetha zamathambo zanamhlanje:

1. I-Interlocking Misumari ya ndani ya mfupa (I-Solid vs. I-Cannulated)

Ukhetho phakathi koyilo lwezikhonkwane oluqinileyo kunye noluqholiweyo luchaphazela kakhulu ukuhamba komsebenzi wotyando kunye nokuphiliswa kwamathambo ebhayoloji.

• I-Cannulated Misumari ya ndani ya mfupa  : Ezi zikhonkwane zineziko elingenanto, ezivumela ukuba zifakwe phezu kwentambo yesikhokelo. Olu luyilo luvumela oogqirha botyando ukuba benze ukufakwa kwe-reamed, eyandisa i-medullary canal, ivumela isikhonkwane esikhulu, esomeleleyo, kwaye ifake amaqhekeza amathambo asekuhlaleni ngokuthe ngqo kwindawo yokwaphuka ukukhawulezisa ukuphiliswa.

• I-Solid Misumari ya ndani ya mfupa : Ngokuyintloko isetyenziswe kwiindlela ezingabonakaliyo, izikhonkwane eziqinileyo zihlala zikhethwa kwiindawo ezivulekileyo ezivulekileyo okanye kwiimeko ze-polytrauma ukunciphisa umngcipheko we-fat embolism kunye nokunciphisa ukuphazamiseka kokunikezelwa kwegazi endosteal.

2. Izikhonkwane zeCephalomedullary & Proximal Femoral Systems

Ukuqhekeka okwenzeka ekupheleni kwe-femur (ummandla we-hip), izikhonkwane eziqhelekileyo ezidibeneyo azanelanga. Iinkqubo ezikhethekileyo ze-cephalomedullary ziyafuneka ukuphatha imithwalo enzima ye-physiological.

• ULungiselelo lokutshixa uLwakhiwo : Olu luyilo lubonisa imingxunya ekhethekileyo yokulandelela esondele kwi-engile emalunga ne-130 ukuya kwi-135 degrees, evumela izikrufu ze-heavy-duty lag ukuba zidlule kwisikhonkwane ngqo kwintloko ye-femoral, zikhusele i-subtrochanteric okanye i-ipsilateral femoral shaft fractures.

• IiNkqubo ze-Anti-Rotation Helical Blade : Isetyenziswa kakhulu kwi-geriatric hip fractures, ezi nkqubo zithatha indawo ye-screws ye-lag yesiko kunye ne-compression blade. Olu yilo lucinezela ithambo elirhangqileyo elirhoxisayo endaweni yokulisusa, linciphisa kakhulu umngcipheko wokufakelwa 'ukusika' kwithambo le-osteoporotic.

3. Retrograde vs. Anterograde Long-Bone Nails

Ngokuxhomekeke kwindawo yokuphuka kunye nokunyaniseka kwezicubu ezithambileyo, oogqirha botyando kufuneka bakhethe ii-portal zokungena ezichaseneyo zokufakwa kwezikhonkwane.

• I-Anterograde Sourcing : Ukufakelwa kwezinto ezifakwe kwisiphelo esisondeleyo (umzekelo, ukungena kwi-trochanter ye-femur fracture). Oku kufuna ukugoba okuchanekileyo ukuze kutshatise ukugoba kwendalo ye-anatomical.

• I-Retrograde Sourcing : Ukufakelwa kwezinto ezifakwe kwi-distal end (umzekelo, ukungena ngaphezu kwedolo elihlangeneyo). Izikhonkwane ezikhethekileyo ze-retrograde femoral zibonisa iipateni zokutshixa ezikhethekileyo ze-distal ukukhusela i-distal yesithathu ye-supracondylar fractures.

Iingxilimbela zoShishino lweHlabathi kunye neempawu eziKhokelayo

1. Stryker Corporation

Umdlali ogqwesileyo kwi-Spain's tier-1 yekliniki yabucala kunye namaziko okwenzakala kwiyunivesiti ephezulu, iStryker ese-US ithathelwa ingqalelo kakhulu ngobunjineli bayo obuchanekileyo kunye nenkxaso yorhwebo eyomeleleyo.

• IiMveliso eziPhambili: Ukutshintshwa okudibeneyo, iiplatifomu ezincedisa i-robotic (i-Mako), izixhobo ze-neurotechnology, kunye neenkqubo eziphambili zokulungiswa kwe-trauma.

• Ipotfoliyo engundoqo: I-Gamma4 Trochanteric Nail System kunye ne-T2 Alpha Interlocking Nail System inika uzinzo oluphezulu lomatshini kunye noqwalaselo lwezixhobo ezijoliswe kuzo.

2. DePuy Synthes (Johnson & Johnson MedTech)

Ukubamba isikhundla esinzulu kuwo omabini amacandelo karhulumente (SNS) kunye nezibhedlele zabucala eSpain, i-DePuy Synthes iphakamisa amashumi eminyaka yophando lwezonyango oluxhaswa yi-AO Foundation.

• IiMveliso eziPhambili: Iinkqubo ze-trauma ezibanzi, izisombululo zokuvuselela ngokubambisana, izixhobo ze-craniomaxillofacial, kunye ne-spinal biomaterials.

• Ipotfoliyo enguNdoqo: Inkqubo yeNgcali yezikhonkwane kunye ne-TFNA (i-Trochanteric Fixation Nail Advanced) isebenzisa unyango lwentsimbi lomnini olulungiselelwe i-trochanteric enzima kunye nokwaphuka kwamathambo amade.

3. CZMEDITECH

Njengendlu yamandla eyaziwayo kwihlabathi kwizixhobo zonyango zamathambo, CZMEDITECH iseke indawo yobonelelo olwandiswayo kwimarike yaseMazantsi Yurophu, ngakumbi ngaphakathi eSpain. Eyaziwa ngokuvala umsantsa phakathi kobunjineli obuchanekileyo bomgangatho waseJamani kunye nokhuphiswano oluphezulu lwemveliso, inkampani ibonelela ngephothifoliyo ebanzi yokwenzakala ebambe iziqinisekiso zonyango ezingqongqo zamazwe aphesheya-kubandakanya ISO 13485, CE iziqinisekiso-iyenza iqabane elifanelekileyo kwizibhedlele ezinkulu ezinikezela ngenkathalo yezempilo yabucala kunye nokubonelela ngezempilo kwi-Universitario. Izikhokelo zokuThengwa kweeMpahla zoLuntu zaseYurophu.

• IiNkqubo zeTrauma ye-Orthopedic: I-Advanced Interlocking Misumari ya ndani ya mfupa , Anatomical Locking Plates & Izikrufu , kunye Iinkqubo zoLungiso lwangaphandle.

• Izisombululo zoLungiso lweSpine : I-Anterior / Posterior Cervical & Thoracolumbar Systems, i-Interbody Fusion Cages, kunye ne-Spinal Fixation Rods.

• I-Cranio-Maxillofacial ( CMF I-Implants : I-Ultra-low profile ye-Titanium Plates kunye Umnatha Iinkqubo zokuvuselela ubuso.

• Izixhobo zaMandla okuSebenza kunye neZincedisi: Ukusebenza okuphezulu Isixhobo sokubhola amathambo s, iiSaws eziOscillating, kunye neekiti zesixhobo sokwenza inzalo.

• Customized OEM/ODM Iinkonzo : Ukwenziwa kwesixhobo sonyango esisekugqibeleni esilungiselelwe inkcukacha zezibhedlele zehlabathi.

• IPotfoliyo Yezikhonkwane ze-IM kunye noNxibelelwano:

  • I-Femoral Msumari wa ndani ya mfupa : Yenziwe kwi-implant-grade Titanium Alloy (Ti-6Al-4V ELI), ene-curvature ye-anatomical ephuculweyo kunye ne-multi-planar locking configurations ukubonelela ukulungiswa okuqinileyo kwiifractures ze-shaft eziyinkimbinkimbi.

  • I-Tibial Msumari wa ndani ya mfupa : Idizayinelwe ngenkqubela phambili yokutshixa okuguquguqukayo okukhethwa kukho kunye neprofayili ye-cannulated, ukukhuthaza ubunzima bokuqala kunye nokukhawuleza ukuphulukiswa kwamathambo.

  • I-Humeral Msumari wa ndani ya mfupa : Isisombululo esikhethekileyo esiphezulu esiphezulu esiququzelela indlela encinci, ukunciphisa ukuphazamiseka kwezicubu ezithambileyo kunye nokukhusela i-rotator cuff.

  • I-Proximal Femoral Nail Antirotation - PFNA : Iquka inkqubo ye-helical blade elungiselelwe izigulane ze-geriatric ezine-osteoporotic bone structures, eziqinisekisa ukuxhathisa okuphakamileyo ngokuchasene nokusikwa ngexesha lokulungiswa kwe-trochanteric fracture.

4. Zimmer Biomet Holdings, Inc.

I-Zimmer Biomet idibanisa amaqonga okhathalelo lwempilo yedijithali kunye ne-premium ye-musculoskeletal fixation technologies, ekhonza iinkqubo ezinkulu zezempilo kwi-metropolitan kwi-Spain.

• IiMveliso eziPhambili: Iimetriki zempilo ezilungelelanisiweyo zedijithali, ukutshintshwa ngokudibeneyo, izixhobo zamayeza ezemidlalo, kunye nokufakelwa kwe-trauma.

• IPotfoliyo Engundoqo: Inkqubo Yezikhonkwane zeNdalo ineegophe ze-anatomical eziyilelwe ukulingana neemophologies zezigulana ezahlukeneyo kwizizwe ngezizwe zaseYurophu.

5. Smith & Nephew plc

Ngokusebenza ngokuthe ngqo okusebenzayo kunye nee-hubs ze-Logistics ezomeleleyo kulo lonke elaseNtshona Yurophu, i-UK-based Smith & Nephew igqwesa kukhathalelo oluphezulu lwenxeba kunye neenkqubo ezikhethekileyo zokwenzakala.

• IiMveliso eziPhambili: Iinkqubo zokulawula amanxeba aphezulu, izixhobo zokubonwa kwe-arthroscopy, kunye ne-hardware ye-orthopedic trauma.

• Ipotfoliyo enguNdoqo: Inkqubo ye-TRIGEN Interlocking Nail System ibonakalisa umphezulu okhethekileyo ogqityiweyo olungiselelwe ulawulo oluqatha lwelungu elisezantsi kunye nokwaphuka kwe-humeral.

6. B. Braun Melsungen AG (Aesculap)

Emele incopho yobunjineli baseJamani enembali enkulu kunye nobukho benkampani eSpain (ikomkhulu e-Rubí, e-Barcelona), i-B. Braun ibonelela ngamaziko eklinikhi aseSpain ngolungelelwaniso lokwenzakala oluhlala ixesha elide, oluchanekileyo.

• IiMveliso eziPhambili: Iinkqubo zonyango lwe-infusion, izixhobo zotyando, ukufakelwa komgogodla, kunye ne-hardware ye-trauma yesakhiwo.

• Ipotifoliyo engundoqo: Inkqubo yeTargon eHlangeneyo yeNail ibonelela ngokuchaneka okuphezulu kokutshixa ngokufuna ukwakhiwa kwakhona kwethambo elide le-femur kunye nezakhiwo ze-tibia.

7. I-Medtronic plc

Ngelixa ixhaphake kakhulu kwizincedisi-ntliziyo kunye nezixhobo zomqolo, i-osteo-division yesakhiwo se-Medtronic ibonelela kwiimfuno ezintsonkothileyo zokulungiswa komonzakalo phakathi kwamaqela ezempilo engingqi yaseSpain.

• IiMveliso eziPhambili: I-hardware yomgogodla, iiplatifomu ezihamba phambili zokuhamba, izixhobo ze-neurosurgery, kunye nokufakelwa kwe-trauma ekhethekileyo.

• Ipotfoliyo enguNdoqo: Uyilo lwezixhobo eziguquguqukayo ezidityaniswe nolungelelwaniso oludityanisiweyo lwendalo yonke olulungele ukwakhiwa ngokutsha kwamathambo anzima.

8. Orthofix Medical Inc.

Orthofix igqwesile ekudibaniseni ifilosofi yangaphakathi nengaphandle, enikezela ngeendlela ezizodwa zokuhlaziya ibhayoloji kwiingcali zamathambo kulo lonke elaseSpain.

• IiMveliso eziphambili: Iifreyimu zokulungisa zangaphandle, unyango lokuvuselela amathambo, kunye neendibano ezikhethekileyo ze-intramedullary-lengthening.

• Iipotifoliyo ezingundoqo: Iinkqubo ezikhethekileyo zabantwana kunye nezikhonkwane ezincinci ezigxile ekulawuleni i-intertrochanteric enzima okanye iziphene zamathambo e-shaft.

9. Acumed LLC

I-Acumed igxile ekuchanekeni kwe-anatomical yokwaphuka okuphezulu, ibonelela ngezixhobo ezikhethekileyo ezithandwa ligxalaba kunye neengcali ezingaphantsi kwemilenze kwizibhedlele eziphambili zaseSpain.

• Iimveliso eziphambili: I-Anatomical Locking Plates , iinkqubo ze-osteotomy ezikhethekileyo, kunye neentonga ezijoliswe kwi-intramedullary ephezulu.

• Ipotfoliyo Engundoqo: Izikhonkwane ze-humeral ze-intramedullary ezikwiprofayili esezantsi kunye neentonga zengalo zangaphambili eziyilelwe ukuthomalalisa ukufakwa kwezicubu ezithambileyo.

10. Globus Medical, Inc.

Ukulandela ukudityaniswa kwayo kwiprofayili ephezulu yamva nje kunye neNuVasive, iGlobus Medical iye yandisa ngokukhawuleza ukwenzakala kwayo kunye nokwakhiwa kwakhona kuthungelwano lwezempilo lwabucala kuMazantsi eYurophu.

• IiMveliso eziphambili: Izisombululo ezibanzi ze-musculoskeletal, i-hardware ye-spinal ephezulu, kunye ne-robotic-assisted trauma navigation.

• Ipotfoliyo enguNdoqo: Inkqubo yeCAPTIVATE yeTrauma, enesixhobo esilungelelanisiweyo esenzelwe ukudibanisa ngokufanelekileyo kwe-femur kunye ne-tibia.

11. I-Wright Medical Group NV (iNkampani ye-Stryker)

Ukusebenza ngaphakathi kwintsapho ye-Stryker trauma, i-Wright Medical's legacy esezantsi kunye ne-foot-and-ankle hardware ihlala iyona khetho ephezulu yokwakhiwa ngokutsha okudibeneyo kunye nokudibanisa eSpain.

• IiMveliso eziPhambili: Ukufakelwa kwamathambo aphezulu, ukutshintshwa kwe-ankle iyonke, kunye ne-orthobiologic bone grafts.

• Ipotfoliyo engundoqo: I-Retrograde retrograde hindfoot kunye ne-ankle fusion rods eyilelwe utyando olunzima lwe-arthrodesis.

12. Aap Implantate AG

I-Aap Implantate ngumvelisi osekwe eJamani owamkelwa ukwazisa izinto ezintsha zokuhombisa zesilivere kunye nobuchwepheshe bokutshixa be-antibacterial eyenzelwe ukunciphisa usulelo olunxulumene nokufakelwa.

• IiMveliso eziPhambili: I-LOQTEQ Locking Plate i-antibacterial trauma implants efakwe kwintsapho kunye nesiliva.

• Ipotfoliyo engundoqo: Iisistim ze-titanium ezidibeneyo kunye neziqinileyo ezakhelwe ukunciphisa iingxaki zasemva kokusebenza ngexesha lokungenelela kwamathambo amade.

13. CarboFix Orthopedics Ltd.

ICarboFix nguvulindlela kwitekhnoloji ye-carbon-fiber, ebonelela ngexabiso elikhethekileyo lotyando olunxulumene ne-oncology kumaziko omhlaza akhethekileyo eSpain.

• IiMveliso eziPhambili: Iiplate ze-polymer eziqiniweyo zeCarbon fiber, izikhonkwane zekhabhoni zesakhiwo, kunye nokufakelwa kwe-radiolucent trauma.

• Ipotfoliyo enguNdoqo: Izikhonkwane zePiccolo Composite, ezivumela umfanekiso ocacileyo, ongenazo izinto zakudala ngexesha lokulandelelwa kwe-oncological kunye nokujolisa kunyango lwemitha.

14. I-MicroPort Scientific Corporation

Isebenzisa isiseko semizi-mveliso esongezelelekileyo, iMicroPort isasaza iindleko zokonga, umthamo ophezulu wokhetho lwentliziyo kunye nonyango lwamathambo kuwo onke amajelo aseMazantsi eYurophu ukuhlangabezana nemiqobo yohlahlo lwabiwo-mali lwesibhedlele.

• Iimveliso eziphambili: I-stents ye-cardiovascular invasive encinci, i-prostheses edibeneyo, kunye ne-hardware yokulungiswa kwe-trauma epheleleyo.

• Ipotfoliyo enguNdoqo: Iisistim zezikhonkwane ze-intramedullary ezenzelwe ukuphinda-phinda, ubuchule bokufaka obulungelelanisiweyo.

15. Wego Ortho (Weigao Group)

I-Wego Ortho yenye yeendibano ezinkulu zonyango zase-Asiya, inikezela ngokufakelwa kwemigangatho yezonyango ethembekileyo ehlangabezana neemfuno ezingqongqo zeklinikhi zaseYurophu.

• IiMveliso eziPhambili: Izixhobo zokulungisa umqolo, iipleyiti ze-structural trauma, i-prostheses edibeneyo, kunye nezinto ezisetyenziswayo zotyando eziyinyumba.

• Ipotfoliyo enguNdoqo: Uluhlu olubanzi lwezikhonkwane ezidityanisiweyo ze-titanium ezilungiselelwe izivumelwano zethenda zengingqi zoluntu eSpain.

── IMVELISO YOKUKHETHA MATRIX ──

Imibuzo Ebuzwa Rhoqo (FAQ)

I-Q1: Ngaba izikhonkwane ze-intramedullary ezifunekayo kwimarike yaseSpain zidinga CE Ukumakisha phantsi kwe-EU MDR?

Ewe, ngokupheleleyo. Ukulandela ukunyanzeliswa okupheleleyo kwe-European Medical Device Regulation (MDR 2017/745), zonke izikhonkwane ze-intramedullary ezithengiswa eSpeyin kufuneka zithwale isiqinisekiso CE esifanelekileyo phantsi kwezikhokelo ze-MDR . IKlasi ye-IIb kunye neKlasi ye-III Izifakelo zamathambo ijongene novavanyo olungqongqo lwezonyango, uphicotho-zincwadi lwamaxwebhu obugcisa, kunye nolandelelo lwezonyango lwasemva kokuthengisa (PMCF). Abaphathi beentengo kufuneka baqinisekise ukuba nawuphi na umenzi wamazwe ngamazwe, njenge- CZMEDITECH , unikezela ngeSibhengezo sokuThotyelwa kwaye ubhaliswe ngokupheleleyo kwi- database ye-EUDAMED .

I-Q2: Ziziphi iimfuno ezikhethekileyo zokubhalisa kunye ne-AEMPS yaseSpain?

Nokuba unophawu olusebenzayo CE , nasiphi na isixhobo sonyango esisasazwa ngaphakathi eSpain kufuneka saziswe kwi- AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) nge- Aplicación de Comunicación de Comercialización de Productos Sanitarios (CCPS). Abarhwebi abavela kumazwe angaphandle kunye nabasasazi bendawo kufuneka kwakhona babe neLicencia Previa de Funcionamiento de Instalaciones (iPhepha-mvume lokuSebenza kwaPhambi kweZibonelelo), beqinisekisa ukongamela okupheleleyo kwasekhaya phambi kokuba iimveliso zibe nokubhidelwa ngokusemthethweni kwiithenda zengingqi.

I-Q3: Kutheni iinkqubo ze-Helical Blade (ezifana ne-PFNA) zibekwe phambili kakhulu kwiinkonzo zempilo zengingqi (umzekelo, i-SERMAS, i-SAS)?

ISpain ineyona ndawo iphakamileyo elindelekileyo yokuphila kunye neyona ndawo indala yabantu eYurophu, ekhokelela kumthwalo omkhulu wokuqhekeka kwe-osteoporotic proximal femoral. Izikrufu zesiqhelo ze-lag zihlala zisilela ngoomatshini 'ukusika-ngaphandle' kwithambo elibuthathaka. Ukufumana iinkqubo eziphambili ezifana ne- CZMEDITECH 's PFNA, esebenzisa i-helical blade eguquguqukayo ukuxinzelela kunokuba ikhuphe izicubu zethambo, inyusa uzinzo olujikelezayo kwaye ithintele ngokubonakalayo ukufundwa kwesibhedlele esinexabiso eliphezulu kunye nohlaziyo-iikhrayitheriya eziphambili zokufumana amanqaku kwiikontrakthi zonikezelo zeminyaka emininzi yoluntu.

I-Q4: Umthetho wethenda woluntu waseSpain (LCSP) unachaphazela njani ukufunwa kwezikhonkwane ze-IM?

Ngaphantsi koMthetho weZibhambathiso zeCandelo loLuntu lwaseSpain ( Ley de Contratos del Sector Público - LCSP ), ukuthengwa kwesibhedlele sikarhulumente akunakusekelwe kuphela kwixabiso. Iithenda zakhiwe malunga nokuThengwa okuSekwe kwiXabiso , apho ukufaneleka kwezobugcisa (ukuthotyelwa kwezinto ezifana neBanga lesi-5 le-Titanium ASTM F136, i-ergonomics ye-instrumentation, ukulandelwa, kunye neenkcukacha zekliniki) zifikelela kwi-50-60% yamanqaku ewonke. Abavelisi ababonelela ngeeprofayili zoomatshini beprimiyamu ngokusebenza kakuhle kolungiselelo (okufana ne- CZMEDITECH ) babambe umngcipheko oqinileyo wokukhuphisana.

I-Q5: Luluphi ulawulo lokulandelelwa olufunekayo kwizikhonkwane ze-intramedullary ngaphakathi kwezibhedlele zaseSpain?

ISpain inyanzelisa ngokungqongqo inkqubo ye -UDI (Unique Device Identification) phantsi kwegunya le-EU. Isikhonkwane ngasinye se-intramedullary kunye ne- Isikrufu sokutshixa kufuneka ibonise inkqubo yokulandela ibhakhowudi (DataMatrix) ebonelela ngokulandeleka okupheleleyo ukusuka kumenzi ukuya kwirekhodi yempilo ye-elektroniki yesigulana (EHR). Abasasazi bendawo kufuneka bagcine iinkqubo zokulandela umkhondo weqashiso/ibhetshi engenakufezekiswa ukuze benze ukukhumbula ngokukhawuleza okanye izilumkiso zokhuseleko ukuba ziphawulwe yi-AEMPS.

I-Q6: Ngaba amaqela okhathalelo lwempilo yaseSpain angadibanisa imigca emininzi yokwenzakala evela kumenzi omnye wamazwe ngamazwe?

Ewe, kwaye oku kukhuthazwa kakhulu kwiindleko kunye nokuphucula ulawulo. Ukudibanisa imigca yokwenzakala ngeqabane elinye elithe ngqo okanye umsasazi ogunyazisiweyo womthombo omnye uvumela amaqela ezibhedlele zaseSpain (ezifana ne-HM Hospitales okanye iQuirónsalud) okanye ukuthengwa kwengingqi ukuze kuxhamle kuqoqosho lwesikali. I-Sourcing evela kumvelisi odibeneyo onjenge- CZMEDITECH ivumela inethiwekhi yesibhedlele ukuba ifumane izikhonkwane ze-Femoral, i-Tibial Nails, i-anatomical Locking Plates , kunye ne- Zana za umeme za matibabu ngaxeshanye-ukulungelelanisa ulawulo lwe-invoyisi yolawulo, ukunciphisa imithwalo yekhabhoni ehambelana nomthwalo, kunye nokuqinisekisa ukucwangciswa okusemgangathweni kwezixhobo zokusebenza zenethiwekhi kwiindawo zokusebenza.

Ukuqukumbela

Ngelixa iibrendi zemveli zaseMntla Melika kunye nakuMbindi Yurophu ziqhubeka nokubamba izabelo ezibalulekileyo zezentengiso kumaziko e-Spain tier-1, ukunyuka kwamabango emali kwiSistema Nacional de Salud (SNS) kuqhubele phambili ukubheka phambili, kubavelisi abaqinisekisiweyo behlabathi. Ababoneleli abanje nge CZMEDITECH banikezela ngexabiso elikhulu elinyanzelisayo kwiiyunithi zomothuko zangoku zaseSpain ngokuthelekisa izatifikethi zonyango zaseYurophu ( CE MDR) kunye nokufakwa kwemigangatho yemathiriyeli ekrwada enezakhiwo eziphuculwe kakhulu.

Ukuqukumbela

Ngelixa iibrendi zelifa lemveli kuMntla Merika kuMbindi Yurophu ziqhubeka nokubamba izabelo ezibalulekileyo zezentengiso kumaziko e-Spain akwinqanaba loku-1, ukunyuka kweemfuno zemali kwiSistema Nacional de Salud (SNS) kuqhubele phambili ukubheka phambili, kubavelisi abaqinisekisiweyo behlabathi. Ababoneleli bayathanda CZMEDITECH hambisa isiphakamiso sexabiso esinyanzelisayo kwiiyunithi ze-trauma zaseSpain zanamhlanje ngokuthelekisa iziqinisekiso zonyango ze-premium zaseYurophu ( CE / ISO ) kunye nokufakelwa kwe-grade-grade imathiriyeli enezakhiwo zokuvelisa eziphuculwe kakhulu.