TEKNIMED

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3009747547	3009747547	TEKNIMED SAS (labeling & distribution)	1	N	2020-04-25	ZI de la Herray VIC en BIGORRE (France) Hautes-Pyrenees FR 65500
3009969323	3009969323	TEKNIMED, INC.	1	Y	2020-04-25	4118 N. Nashville Ave. Chicago IL US 60634

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
216801	1511646395	K083005	NANGEL	LYC	2009-03-04
216801	2038247422	K080873	OPACITY + BONE CEMENT	NDN	2008-08-28
216801	1270169860	K060300	CONFIDENCE HIGH VISCOSITY BONE CEMENT	NDN	2006-06-21
216801	1071435466	K040669	CERAFORM BONE VOID FILLER	MQV	2004-05-03
216801	1950897417
216801	1961965516

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
NDN	2	2008-08-28
LYC	1	2009-03-04
MQV	1	2004-05-03

PMN

GENTAFIX® (1, 3, 3MV)

2024-12-18

Teknimed Sas

EUROSCREW NG; EUROSCREW TCP NG

2023-05-12

Teknimed

HIGH V+

2017-04-12

Teknimed, SAS

COHESION BONE CEMENT

2011-02-04

TEKNIMED, S.A.S.

F20

2011-01-03

TEKNIMED SA

VERTECEM

2009-12-21

TEKNIMED SA

NANGEL

2009-03-04

TEKNIMED SA

OPACITY + BONE CEMENT

2008-08-28

TEKNIMED SA

ODONCER

2007-04-16

TEKNIMED SA

SPINE-FIX BIOMIMETIC BONE CEMENT

2006-03-17

TEKNIMED SA

CEMENTEK LV

2004-12-27

TEKNIMED SA

CEMENTEK

2004-08-19

TEKNIMED SA

CERAFORM BONE VOID FILLER

2004-05-03

TEKNIMED SA

TRIHA +

2003-11-28

TEKNIMED SA

CEMSTOP CEMENT RESTRICTOR

2003-11-26

TEKNIMED SA

GUDID

Dynamo - Spinal Cement – MV

TEKNIMED

2026-02-02

Dynamo - Spinal Cement System Syringe MV 1.5cc

TEKNIMED

2026-02-02

Dynamo - Spinal Cement System Syringe MV 4cc

TEKNIMED

2026-02-02

Dynamo - Spinal Cement System Gun MV

TEKNIMED

2026-02-02

Signature -x Cement - SV

TEKNIMED

2026-01-23

Signature -x Cement - LV

TEKNIMED

2026-01-23

Signature -x Cement - MV

TEKNIMED

2026-01-23

GENTAFIX - 1

TEKNIMED

2025-09-02

GENTAFIX - 3

TEKNIMED

2025-09-02

GENTAFIX - 3 MV

TEKNIMED

2025-09-02

PureKit Syringe 1.5cc MV - T060428MV

TEKNIMED

2025-03-31

META+ System 1.5cc MV - T040352MV

TEKNIMED

2025-03-31

PUREKIT Syringes - T060426

TEKNIMED

2025-03-31

Syringes 4cc - T060427

TEKNIMED

2025-03-31

Syringes 1.5cc - T060428

TEKNIMED

2025-03-31

PureKit Gun MV - T060425MV

TEKNIMED

2023-03-30

OPACITY + - T040320Z

TEKNIMED

2015-10-16

F20 - T040520

TEKNIMED

2015-10-16

HIGH V+ - T040321

TEKNIMED

2017-08-22

EXOFIX - T040323

TEKNIMED

2015-10-16

EUROSCREW NG Screwdriver Shaft - T067234

TEKNIMED

2024-01-22

Ratchet Handle - T067228

TEKNIMED

2024-01-22

TAP NG - Ø6

TEKNIMED

2024-01-19

TAP NG - Ø7

TEKNIMED

2024-01-19

TAP NG - Ø8

TEKNIMED

2024-01-19

TAP NG - Ø9

TEKNIMED

2024-01-19

TAP NG - Ø10

TEKNIMED

2024-01-19

TAP NG - Ø11

TEKNIMED

2024-01-19

B-screw TCP - Ø06 L20

TEKNIMED

2023-12-18

B-screw TCP - Ø07 L24

TEKNIMED

2023-12-18

B-screw TCP - Ø07 L30

TEKNIMED

2023-12-18

B-screw TCP - Ø08 L24

TEKNIMED

2023-12-18

B-screw TCP - Ø08 L30

TEKNIMED

2023-12-18

B-screw TCP - Ø09 L24

TEKNIMED

2023-12-18

B-screw TCP - Ø09 L30

TEKNIMED

2023-12-18

B-screw TCP - Ø10 L30

TEKNIMED

2023-12-18

B-screw TCP - Ø11 L35

TEKNIMED

2023-12-18

Euroscrew NG - Ø6 L20

TEKNIMED

2023-12-18

Euroscrew NG - Ø7 L24

TEKNIMED

2023-12-18

Euroscrew NG - Ø7 L30

TEKNIMED

2023-12-18

156 records. Showing 1-40. Next