Medical Device Manufacturer · US , Allendale, , NJ

Howmedica Osteonics - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2001

13

Total

13

Cleared

0

Denied

FDA 510(k) cleared devices by Howmedica Osteonics Orthopedic ✕

13 devices

1-13 of 13

Cleared Mar 29, 2012

ACCOLADE II HIP STEM

Orthopedic · 31d

Cleared Mar 03, 2011

RESTORATION ACETABULAR WEDGE AUGMENTS

Orthopedic · 227d

Cleared Jan 22, 2007

TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT

Orthopedic · 70d

Cleared Mar 09, 2004

BONESAVE BONE VOID FILLER

Orthopedic · 152d

Cleared Dec 10, 2003

STRYKER SPINE MAPS SYSTEM

Orthopedic · 89d

Cleared Aug 08, 2003

REFLEX ANTERIOR CERVICAL PLATE SYSTEM

Orthopedic · 67d

Cleared Aug 04, 2003

Orthopedic · 90d

Cleared May 23, 2003

GMRS PRESS FIT STEMS WITH PUREFIX HA

Orthopedic · 36d

Cleared Aug 22, 2002

S2 FEMORAL NAIL

Orthopedic · 27d

Cleared Aug 01, 2002

XIA SPINAL SYSTEM

Orthopedic · 29d

Cleared Dec 03, 2001

MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

Orthopedic · 20d

Cleared Oct 10, 2001

DURACON PS LIPPED TIBIAL INSERT

Orthopedic · 90d

Cleared Jul 20, 2001

MODIFICATION TO XIA SPINE SYSTEM

Orthopedic · 22d