Kuluvuyo ukwazisa ukuba imveliso epheleleyo yeZATH ifumene imvume yeCE.Iimveliso ziquka:
1. I-hip prosthesis eyinyumba - iClass III
2. I-Screw ye-Metal Bone Screw engenazintsholongwane / engabonakaliyo - i-Class IIb
3. I-Spinal Internal Fixation System eyiNzalo / engabonakaliyo - i-Class IIb
4. INtsholongwane/iSixokelelwano sePlate yokutshixa iNtsholongwane - iKlasi ye-IIb
5. I-Screw eNyinyumba/esingenantsholongwane-Udidi IIb
6. INtsholongwane eNgcono/engazaliyo i-Interbody Fusion Cage - iKlasi ye-IIb
7. INtsholongwane/engazaliyo iSakhelo sokuLungisa saNgaphandle (ngephini) - Udidi IIb,
Ukwamkelwa kwe-CE kubonisa ukuba imveliso epheleleyo yeZATH ihambelana nemigangatho efanelekileyo kunye nemimiselo ye-EU, kwaye ivula indlela yokungena kwimarike yaseYurophu kunye neminye imimandla yehlabathi.
Iphothifoliyo yemveliso evunyiweyo iqulethe i-ZATH trauma (i-plate yokukhiya, i-screw bone, i-screw cannulated kunye ne-fixator yangaphandle), umqolo (ukulungiswa kwangaphakathi komgogodla kunye neenkqubo zokudibanisa) kunye neenkqubo zokutshintshwa ngokubambisana (i-hip joint).Kwangaxeshanye, ukongeza kwiimveliso ezidityanisiweyo, i-ZATH's trauma kunye neemveliso zomqolo zikwafumaneka kwipakethe efakwe inzala, enokuthi inganciphisi kuphela izinga losulelo kwizigulana, kodwa iphucule ireyithi yokuthengiswa kwempahla yamaqabane ethu okusasaza.Okwangoku, i-ZATH kuphela komvelisi wamathambo emhlabeni obonelela ngokupakishwa kwe-sterilized kuwo wonke umgca wemveliso.
Ukugqithiswa kwexesha elinye kwesatifikethi se-CE somgca wemveliso opheleleyo akubonisi nje kuphela amandla obugcisa aqinileyo kunye nomgangatho ogqwesileyo we-ZATH, kodwa ikwabeka isiseko esiluqilima sokuthatha amanyathelo angaphezulu kwimarike yamazwe ngamazwe.
Ngophuhliso lweminyaka engaphezulu kwe-10, i-ZATH iseke ubudlelwane bentsebenziswano kumazwe amaninzi asuka kwimimandla yaseYurophu, yaseAsia, eAfrika naseLatin America.Kungakhathaliseki ukuba ukwenzakala kunye neemveliso zomqolo, okanye iimveliso ezitshintshwa ngokudibeneyo, zonke iimveliso ze-ZATH zifumana ukuqondwa okuphezulu kumaqabane ayo aphesheya kunye noogqirha kwihlabathi liphela.
Ngemvume yeCE, siya kuthabatha eli thuba ukuze siqalise uhambo olutsha kwintsimi yamathambo ehlabathini lonke.
Ixesha lokuposa: Aug-29-2022