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
101-125 of 285
Cleared Mar 21, 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · HRS
Orthopedic · 20d
Cleared Mar 04, 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · KTT
Orthopedic · 53d
Cleared Feb 16, 2005
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
K043374 · MBH
Orthopedic · 70d
Cleared Feb 16, 2005
GAMMA3 NAIL SYSTEM
K043431 · HSB
Orthopedic · 65d
Cleared Feb 11, 2005
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL...
K041940 · LZO
Orthopedic · 207d
Cleared Feb 10, 2005
TRIDENT ACETABULAR SYSTEM
K033716 · LPH
Orthopedic · 442d
Cleared Feb 09, 2005
SCORPIO NRG KNEE SYSTEM
K042343 · JWH
Orthopedic · 163d
Cleared Jan 12, 2005
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
K042993 · JWH
Orthopedic · 72d
Cleared Dec 27, 2004
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
K043404 · HSB
Orthopedic · 17d
Cleared Nov 23, 2004
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
K042883 · JWH
Orthopedic · 35d
Cleared Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · LZO
Orthopedic · 189d
Cleared Oct 08, 2004
T2 PROXIMAL HUMERAL NAIL
K042396 · HSB
Orthopedic · 36d
Cleared Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K042019 · KTT
Orthopedic · 59d
Cleared Sep 23, 2004
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
K041591 · JWH
Orthopedic · 101d
Cleared Sep 08, 2004
HOFFMANN II FOOT RING
K041706 · KTT
Orthopedic · 77d
Cleared Sep 08, 2004
NUMELOCK II SYSTEM
K041709 · KTT
Orthopedic · 77d
Cleared Aug 25, 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · LZO
Orthopedic · 156d
Cleared Jul 01, 2004
OMEGA 2 SYSTEM
K041001 · KTT
Orthopedic · 73d
Cleared Jun 17, 2004
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K040749 · KRO
Orthopedic · 86d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K033971 · MBH
Orthopedic · 158d
Cleared May 28, 2004
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
K040964 · JWH
Orthopedic · 44d
Cleared May 27, 2004
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160 · KRR
Orthopedic · 24d
Cleared May 05, 2004
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
K040267 · JWH
Orthopedic · 90d
Cleared Apr 12, 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · MBH
Orthopedic · 112d
Cleared Mar 26, 2004
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · HSD
Orthopedic · 65d

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