Medical Device Manufacturer · US , Rutherford , NJ

Howmedica, Inc. - FDA 510(k) Cleared Devices

36 submissions · 29 cleared · Since 1994

36

Total

29

Cleared

0

Denied

FDA 510(k) Regulatory Record - Howmedica, Inc. Orthopedic ✕

33 devices

1-12 of 33

Cleared Feb 24, 1999

XIA SPINE SYSTEM

Orthopedic · 89d

Cleared Feb 05, 1999

HOWMEDICA HUMERAL INTERCALARY SYSTEM

Orthopedic · 73d

Cleared Feb 01, 1999

ZETA MULTIZONE LOCKING NAIL SYSTEM

Orthopedic · 61d

Cleared Nov 18, 1998

G/K SFN AND STN LOCKING NAILS

Orthopedic · 55d

Cleared Aug 31, 1998

HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR...

Orthopedic · 66d

Cleared Jun 26, 1998

RELIANCE LONG STEM FEMORAL COMPONENTS

Orthopedic · 115d

Cleared Jun 10, 1998

ROGACHEFSKY DISTAL RADIUS PLATES

Orthopedic · 63d

Cleared Jun 02, 1998

EXETER INTRAMEDULLARY BONE PLUG

Orthopedic · 90d

Cleared Apr 16, 1998

PARTNERSHIP CALCAR FEMORAL COMPONENTS

Orthopedic · 83d

Cleared Mar 13, 1998

HOWMEDICA(R) FULLY THREADED SCREWS

Orthopedic · 85d

Cleared Feb 12, 1998

EPI-UNION PLATING SYSTEM

Orthopedic · 90d

Cleared Jan 12, 1998

ORBITAL RECONSTRUCTION PLATES

Orthopedic · 84d