Medical Device Manufacturer · US , Warsaw , IN

DePuy Orthopaedics, Inc. - FDA 510(k) Cleared Devices

206 submissions · 204 cleared · Since 1998
206
Total
204
Cleared
0
Denied
198 devices
101-125 of 198
Cleared Nov 22, 2005
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
K053003 · LOD
Orthopedic · 27d
Cleared Oct 21, 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K052079 · KWZ
Orthopedic · 80d
Cleared Oct 06, 2005
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · KWS
Orthopedic · 28d
Cleared Aug 05, 2005
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
K040627 · KWA
Orthopedic · 514d
Cleared May 16, 2005
DELTA HUMERAL CUPS
K050315 · PHX
Orthopedic · 96d
Cleared Feb 11, 2005
CORAIL AMT HIP PROSTHESIS
K042992 · LZO
Orthopedic · 102d
Cleared Jan 21, 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113 · KTT
Orthopedic · 72d
Cleared Dec 22, 2004
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · JDI
Orthopedic · 56d
Cleared Oct 22, 2004
SMARTMIX PRE-FILLED MIXING SYSTEM
K042591 · KIH
Orthopedic · 29d
Cleared Sep 08, 2004
TROCHANTERIC NAIL SYSTEM
K042325 · HSB
Orthopedic · 12d
Cleared Jul 09, 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281 · JWH
Orthopedic · 154d
Cleared Jul 01, 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE...
K041656 · LOD
Orthopedic · 13d
Cleared May 12, 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · LPH
Orthopedic · 85d
Cleared May 06, 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND...
K033273 · LPH
Orthopedic · 209d
Cleared May 05, 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268 · HRY
Orthopedic · 90d
Cleared Apr 08, 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · LZO
Orthopedic · 28d
Cleared Mar 12, 2004
SPECTRUM MODULAR SYSTEM
K033893 · LPH
Orthopedic · 87d
Cleared Feb 23, 2004
DEPUY SIGMA XLK TIBIAL INSERTS
K040166 · JWH
Orthopedic · 28d
Cleared Feb 05, 2004
DEPUY SIGMA TIBIAL INSERTS
K033272 · JWH
Orthopedic · 118d
Cleared Feb 05, 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · LOD
Orthopedic · 105d
Cleared Feb 05, 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · LOD
Orthopedic · 85d
Cleared Jan 08, 2004
PINNACLE REVISION SYSTEM
K033338 · LPH
Orthopedic · 83d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · KXA
Orthopedic · 98d
Cleared Dec 03, 2003
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · HSD
Orthopedic · 26d
Cleared Oct 06, 2003
ACE NANCY NAIL
K032687 · HTY
Orthopedic · 38d

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