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
201-225 of 285
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · HSB
Orthopedic · 29d
Cleared Nov 14, 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · HSB
Orthopedic · 22d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · KWP
Orthopedic · 28d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · HRS
Orthopedic · 51d
Cleared Aug 01, 2001
MODIFICATION TO: LONG LENGTH GAMMA NAIL
K012158 · HSB
Orthopedic · 21d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026 · JDI
Orthopedic · 20d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · LXT
Orthopedic · 22d
Cleared Jun 28, 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643 · JWH
Orthopedic · 30d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL...
K011622 · HSB
Orthopedic · 21d
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · JDI
Orthopedic · 21d
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · HSB
Orthopedic · 26d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · JDW
Orthopedic · 21d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · LPH
Orthopedic · 90d
Cleared Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · MNH
Orthopedic · 28d
Cleared Apr 16, 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · KWQ
Orthopedic · 90d
Cleared Apr 11, 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · JDI
Orthopedic · 29d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · KRR
Orthopedic · 85d
Cleared Apr 06, 2001
T2 FEMORAL NAIL
K010801 · HSB
Orthopedic · 21d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · JDI
Orthopedic · 47d
Cleared Feb 15, 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147 · JWH
Orthopedic · 311d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · JEC
Orthopedic · 30d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923 · LXT
Orthopedic · 90d
Cleared Dec 15, 2000
TITAN TIBIAL NAIL
K003018 · HSB
Orthopedic · 79d
Cleared Dec 15, 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211 · LXT
Orthopedic · 63d
Cleared Dec 11, 2000
TRIDENT ALL POLY CUP
K001956 · JDI
Orthopedic · 167d

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