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
151-175 of 285
Cleared Jul 31, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480 · KRO
Orthopedic · 80d
Cleared Jul 25, 2003
STRYKER PLATING SYSTEM PERIARTICULAR PLATES
K031959 · LXT
Orthopedic · 30d
Cleared Jul 24, 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · JEC
Orthopedic · 30d
Cleared Jul 17, 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · KWP
Orthopedic · 28d
Cleared May 06, 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199 · LOD
Orthopedic · 501d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127 · JDR
Orthopedic · 19d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · KWP
Orthopedic · 17d
Cleared Mar 20, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · LWJ
Orthopedic · 136d
Cleared Feb 03, 2003
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
K023724 · JWH
Orthopedic · 90d
Cleared Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
K023901 · LZO
Orthopedic · 67d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · HWC
Orthopedic · 11d
Cleared Dec 16, 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · KRO
Orthopedic · 90d
Cleared Dec 11, 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · HSB
Orthopedic · 72d
Cleared Nov 21, 2002
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · JDI
Orthopedic · 90d
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703 · JWH
Orthopedic · 254d
Cleared Oct 18, 2002
DURACON CS TIBIAL INSERT
K021451 · JWH
Orthopedic · 165d
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · LZO
Orthopedic · 86d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651 · LXT
Orthopedic · 69d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · MEH
Orthopedic · 21d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · HWC
Orthopedic · 7d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549 · LZO
Orthopedic · 53d
Cleared Aug 26, 2002
S2 TIBIAL NAIL
K022481 · HSB
Orthopedic · 28d
Cleared Aug 26, 2002
ACCOLADE C FEMORAL STEMS
K022555 · LZO
Orthopedic · 24d
Cleared Jul 25, 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · JDI
Orthopedic · 29d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · LPH
Orthopedic · 21d

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