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
126-150 of 285
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394 · MNI
Orthopedic · 200d
Cleared Feb 20, 2004
HANSSON PIN SYSTEM
K033968 · HTY
Orthopedic · 60d
Cleared Feb 13, 2004
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · HSX
Orthopedic · 72d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · KTT
Orthopedic · 78d
Cleared Jan 15, 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · JWH
Orthopedic · 90d
Cleared Jan 15, 2004
GAMMA3 NAIL SYSTEM
K034002 · HSB
Orthopedic · 22d
Cleared Jan 08, 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · MQP
Orthopedic · 29d
Cleared Dec 10, 2003
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · JWH
Orthopedic · 90d
Cleared Nov 20, 2003
SCORPIO NRG KNEE SYSTEM
K030978 · JWH
Orthopedic · 237d
Cleared Nov 05, 2003
HOFFMANN II PELVIC CLAMP
K033145 · LXT
Orthopedic · 36d
Cleared Oct 22, 2003
T2 NAILING SYSTEM
K032523 · HSB
Orthopedic · 68d
Cleared Oct 09, 2003
ACCOLADE-J HIP STEM SERIES
K032300 · MEH
Orthopedic · 76d
Cleared Oct 09, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581 · LPH
Orthopedic · 49d
Cleared Oct 09, 2003
T2 RECON NAIL SYSTEM
K032898 · HSB
Orthopedic · 22d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163 · MBH
Orthopedic · 59d
Cleared Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · MBH
Orthopedic · 37d
Cleared Sep 04, 2003
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K032479 · JWH
Orthopedic · 23d
Cleared Sep 02, 2003
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729 · JWH
Orthopedic · 90d
Cleared Aug 29, 2003
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K031730 · JDI
Orthopedic · 86d
Cleared Aug 29, 2003
S2 NAIL SYSTEM
K032579 · HSB
Orthopedic · 8d
Cleared Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
K031657 · MRW
Orthopedic · 86d
Cleared Aug 08, 2003
OPUS SPINAL SYSTEM
K030369 · NKB
Orthopedic · 185d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · JDI
Orthopedic · 64d
Cleared Aug 08, 2003
GAMMA 3 NAIL SYSTEM
K032244 · HSB
Orthopedic · 17d
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · HSD
Orthopedic · 16d

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