Medical Device Manufacturer · US , Allendale , NJ

Howmedica Osteonics Corp. - FDA 510(k) Cleared Devices

288 submissions · 288 cleared · Since 1999
288
Total
288
Cleared
0
Denied
285 devices
51-75 of 285
Cleared May 16, 2007
UNIVERSAL TAPER DELTA FEMORAL HEAD
K070885 · LZO
Orthopedic · 47d
Cleared May 11, 2007
DURACON X3 CS TIBIAL INSERT
K070883 · MBH
Orthopedic · 42d
Cleared May 11, 2007
ASNIS MICRO CANNULATED SCREW
K071092 · HWC
Orthopedic · 23d
Cleared May 04, 2007
REUNION HA FRACTURE STEM
K070963 · HSD
Orthopedic · 29d
Cleared Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
K070454 · KTT
Orthopedic · 55d
Cleared Mar 15, 2007
STRYKER FOOT PLATING SYSTEM
K063875 · HRS
Orthopedic · 76d
Cleared Mar 08, 2007
PCA CONSTRAINED ACETABULAR LINERS
K063445 · KWZ
Orthopedic · 113d
Cleared Mar 08, 2007
SYSTEM 12 CONSTRAINED ACETABULAR LINERS
K063550 · KWZ
Orthopedic · 104d
Cleared Mar 08, 2007
SERIES II CONSTRAINED ACETABULAR LINERS
K063552 · KWZ
Orthopedic · 104d
Cleared Feb 26, 2007
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
K063857 · MBB
Orthopedic · 60d
Cleared Dec 27, 2006
METAIZEAU NAILING SYSTEM
K063225 · HSB
Orthopedic · 64d
Cleared Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
K063616 · LZO
Orthopedic · 15d
Cleared Dec 13, 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · HSD
Orthopedic · 82d
Cleared Nov 15, 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
K062419 · LPH
Orthopedic · 89d
Cleared Oct 25, 2006
PROFYLE SYSTEM
K062498 · HRS
Orthopedic · 61d
Cleared Oct 03, 2006
SOLAR REUNION FRACTURE STEM
K062113 · KWS
Orthopedic · 71d
Cleared Aug 22, 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434 · LPH
Orthopedic · 90d
Cleared Aug 15, 2006
OMEGA 3 SYSTEM
K062066 · KTT
Orthopedic · 25d
Cleared Aug 11, 2006
TRIATHLON METAL BACKED PATELLA
K061521 · MBH
Orthopedic · 70d
Cleared Aug 03, 2006
TRIATHLON LOW PROFILE TIBIAL TRAY
K062037 · JWH
Orthopedic · 15d
Cleared Jul 18, 2006
PCA 36MM FEMORAL HEADS
K061168 · LPH
Orthopedic · 82d
Cleared Jul 10, 2006
SOLAR PUREFIX HA SHOULDER
K061677 · HSD
Orthopedic · 25d
Cleared Jul 07, 2006
TRIDENT CONSTRAINED ACETABULAR INSERT
K061654 · KWZ
Orthopedic · 24d
Cleared May 19, 2006
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · HRS
Orthopedic · 37d
Cleared Apr 21, 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · KTT
Orthopedic · 45d

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