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
226-250 of 285
Cleared Dec 08, 2000
OPUS ROD FIXATION SYSTEM
K003490 · MNH
Orthopedic · 25d
Cleared Nov 30, 2000
V-40/C-TAPER ADAPTER SLEEVE
K003379 · LZO
Orthopedic · 30d
Cleared Nov 28, 2000
OSTEONICS ALUMINA C-TAPER HEAD
K003391 · LZO
Orthopedic · 28d
Cleared Nov 24, 2000
ALUMINA V40 HEAD
K003413 · LZO
Orthopedic · 22d
Cleared Nov 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · KRO
Orthopedic · 88d
Cleared Oct 13, 2000
XIA SPINE SYSTEM
K002858 · KWQ
Orthopedic · 30d
Cleared Oct 05, 2000
XIA SPINE SYSTEM
K002505 · KWP
Orthopedic · 51d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654 · HWC
Orthopedic · 28d
Cleared Sep 14, 2000
ACCOLADE C FEMORAL COMPONENT
K002320 · LZO
Orthopedic · 45d
Cleared Aug 18, 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · KWP
Orthopedic · 80d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · MEH
Orthopedic · 87d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
K001449 · LZO
Orthopedic · 87d
Cleared Aug 04, 2000
STRYKER TRAUMA PELVIC SET
K001614 · KTW
Orthopedic · 71d
Cleared Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · KWI
Orthopedic · 86d
Cleared Jul 27, 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · HSD
Orthopedic · 83d
Cleared Jul 25, 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · KRO
Orthopedic · 28d
Cleared Jul 19, 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · KWQ
Orthopedic · 30d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886 · JDW
Orthopedic · 21d
Cleared Jun 20, 2000
CALCIUM SULFATE PELLETS
K001559 · MQV
Orthopedic · 32d
Cleared Jun 07, 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · KRO
Orthopedic · 20d
Cleared May 23, 2000
HOFFMANN II EXTERNAL FIXATION SYSTEM
K000957 · LXT
Orthopedic · 60d
Cleared May 23, 2000
XIA SPINE SYSTEM HOOKS
K001319 · MNH
Orthopedic · 27d
Cleared May 11, 2000
STRYKER TRAUMA PLATING SYSTEM
K000636 · HRS
Orthopedic · 76d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · MNI
Orthopedic · 45d
Cleared May 11, 2000
XIA SPINE SYSTEM
K001272 · KWQ
Orthopedic · 21d

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