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
176-200 of 285
Cleared Jun 26, 2002
T2 FEMORAL NAIL
K021744 · HSB
Orthopedic · 29d
Cleared Jun 06, 2002
SCORPIO INSET PATELLAR COMPONENT
K020830 · JWH
Orthopedic · 84d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772 · KTT
Orthopedic · 89d
Cleared May 21, 2002
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K021310 · JDI
Orthopedic · 26d
Cleared May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · MEH
Orthopedic · 77d
Cleared May 06, 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · HSB
Orthopedic · 90d
Cleared Apr 26, 2002
SUPER EON PLUS FEMORAL STEMS
K020989 · JDI
Orthopedic · 30d
Cleared Apr 25, 2002
S2 FEMORAL NAIL
K021026 · HSB
Orthopedic · 27d
Cleared Apr 25, 2002
S2 TIBIAL NAIL
K021027 · HSB
Orthopedic · 27d
Cleared Apr 11, 2002
AVON PATELLAR COMPONENT
K020841 · KRR
Orthopedic · 27d
Cleared Apr 04, 2002
LONG LENGTH GAMMA NAIL
K020773 · HSB
Orthopedic · 27d
Cleared Apr 03, 2002
2 PIECE MODULAR HIP STEM
K013106 · LZO
Orthopedic · 198d
Cleared Mar 29, 2002
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · KWQ
Orthopedic · 29d
Cleared Mar 29, 2002
GAMMA 3 LAG SCREW
K020677 · HSB
Orthopedic · 28d
Cleared Mar 04, 2002
TRIDENT ELEVATED RIM LINER
K020497 · LPH
Orthopedic · 18d
Cleared Mar 04, 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572 · MEH
Orthopedic · 11d
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293 · MNH
Orthopedic · 17d
Cleared Jan 25, 2002
T2 FEMORAL NAIL SYSTEM
K014220 · HSB
Orthopedic · 30d
Cleared Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · KWL
Orthopedic · 30d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · MNH
Orthopedic · 30d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · LPH
Orthopedic · 62d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · KWP
Orthopedic · 30d
Cleared Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676 · MEH
Orthopedic · 28d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · MNH
Orthopedic · 28d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · JWH
Orthopedic · 88d

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