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TEKNIMED SAS

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1099-2023Class IIHIGH V+ Spinal Cement System REF T040321KDecember 15, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K242216GENTAFIX® (1, 3, 3MV)December 18, 2024
K230394EUROSCREW NG; EUROSCREW TCP NGMay 12, 2023
K161114HIGH V+April 12, 2017
K103816COHESION BONE CEMENTFebruary 4, 2011
K103433F20January 3, 2011
K090435VERTECEMDecember 21, 2009
K083005NANGELMarch 4, 2009
K080873OPACITY + BONE CEMENTAugust 28, 2008
K062102ODONCERApril 16, 2007
K043593SPINE-FIX BIOMIMETIC BONE CEMENTMarch 17, 2006
K042911CEMENTEK LVDecember 27, 2004
K041493CEMENTEKAugust 19, 2004
K040669CERAFORM BONE VOID FILLERMay 3, 2004
K031826TRIHA +November 28, 2003
K032685CEMSTOP CEMENT RESTRICTORNovember 26, 2003