Medical Device Manufacturer · US , Cambridge , MA

Etex Corp. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 1994

Recent clearances: CARRIGEN, GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN, CARRIGEN

18

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Etex Corp. Orthopedic ✕

13 devices

1-12 of 13

Cleared Jul 01, 2010

GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

Orthopedic · 27d

Cleared Feb 18, 2010

Orthopedic · 105d

Cleared Nov 02, 2009

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

Orthopedic · 152d

Cleared Sep 18, 2009

EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE

Orthopedic · 172d

Cleared Mar 24, 2009

Orthopedic · 46d

Cleared Feb 20, 2009

GAMMA-BSM, BETA-BSM

Orthopedic · 18d

Cleared Apr 28, 2008

CAP PLUS, EQUIVABONE, CAP/DBM

Orthopedic · 81d

Cleared Nov 19, 2007

Orthopedic · 411d

Cleared Oct 23, 2007

A-BSM BONE SUBSTITUTE MATERIAL

Orthopedic · 35d

Cleared Sep 26, 2007

OSSIFUSE BONE SUBSTITUTE MATERIAL

Orthopedic · 35d

Cleared Jun 28, 2007

OSSIPRO BONE SUBSTITUTE MATERIAL

Orthopedic · 296d

Cleared Dec 02, 2003

CAP3 BONE SUBSTITUTE MATERIAL

Orthopedic · 63d