FDA.reportPublic FDA data

TEKNIMED SAS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96157883003854593TEKNIMED SAS1N2026-01-0111_12 rue d Apollo L Union Haute-Garonne FR 31240
30097475473009747547TEKNIMED SAS (labeling & distribution)1N2020-04-25ZI de la Herray VIC en BIGORRE (France) Hautes-Pyrenees FR 65500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
190241855502502K242216GENTAFIX® (1, 3, 3MV)MBB2024-12-18
190241567291922K230394EUROSCREW NG; EUROSCREW TCP NGMAI2023-05-12
190241082376808K161114HIGH V+NDN2017-04-12
190241033086075K103816COHESION BONE CEMENTNDN2011-02-04
190242045599470K103433F20NDN2011-01-03
190241511646395K083005NANGELLYC2009-03-04
2168011511646395K083005NANGELLYC2009-03-04
190242038247422K080873OPACITY + BONE CEMENTNDN2008-08-28
2168012038247422K080873OPACITY + BONE CEMENTNDN2008-08-28
190241270169860K060300CONFIDENCE HIGH VISCOSITY BONE CEMENTNDN2006-06-21
2168011270169860K060300CONFIDENCE HIGH VISCOSITY BONE CEMENTNDN2006-06-21
190241241231474K043593SPINE-FIX BIOMIMETIC BONE CEMENTNDN2006-03-17
190241071435466K040669CERAFORM BONE VOID FILLERMQV2004-05-03
2168011071435466K040669CERAFORM BONE VOID FILLERMQV2004-05-03
190241134184336K032685CEMSTOP CEMENT RESTRICTORLZN2003-11-26
190241807324568K031826TRIHA +MQV2003-11-28
190241124448905
2168011950897417
190241950897417
190241961965516
2168011961965516
190241156730263
190241291270623
190241518388390
190241770003869

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NDN122017-04-12
MQV52004-05-03
LYC32009-03-04
LZN22003-11-26
MBB12024-12-18
MAI12023-05-12

PMN#