Medical Device Manufacturer · US , Round Rock , TX

Teknimed, S.A. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2003

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Teknimed, S.A. Orthopedic ✕

9 devices

1-9 of 9

Cleared Jan 03, 2011

Orthopedic · 40d

Cleared Dec 21, 2009

Orthopedic · 305d

Cleared Aug 28, 2008

OPACITY + BONE CEMENT

Orthopedic · 150d

Cleared Mar 17, 2006

SPINE-FIX BIOMIMETIC BONE CEMENT

Orthopedic · 443d

Cleared Dec 27, 2004

Orthopedic · 67d

Cleared Aug 19, 2004

Orthopedic · 76d

Cleared May 03, 2004

CERAFORM BONE VOID FILLER

Orthopedic · 49d

Cleared Nov 28, 2003

Orthopedic · 168d

Cleared Nov 26, 2003

CEMSTOP CEMENT RESTRICTOR

Orthopedic · 89d