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
206 devices
126-150 of 206
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
Cleared Sep 29, 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · LOD
Orthopedic · 376d
Cleared Sep 24, 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971 · HSD
Orthopedic · 90d
Cleared Aug 08, 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · HSB
Orthopedic · 31d
Cleared Jul 28, 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · FTM
General & Plastic Surgery · 32d
Cleared Jul 14, 2003
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
K031203 · JWJ
Orthopedic · 89d
Cleared Jul 01, 2003
DEPUY CERAMIC FEMORAL HEADS
K031803 · LZO
Orthopedic · 20d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · LPH
Orthopedic · 29d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · LPH
Orthopedic · 27d
Cleared Feb 13, 2003
SMARTSET HV BONE CEMENT
K023012 · LOD
Orthopedic · 156d
Cleared Feb 05, 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · LWJ
Orthopedic · 22d
Cleared Dec 18, 2002
ACE VERSANAIL
K023115 · HSB
Orthopedic · 90d
Cleared Dec 10, 2002
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · KWA
Orthopedic · 27d
Cleared Nov 13, 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · JDI
Orthopedic · 29d
Cleared Aug 26, 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · KTT
Orthopedic · 75d
Cleared Jul 24, 2002
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · LOD
Orthopedic · 76d
Cleared Jan 28, 2002
DEPUY FEMORAL HEADS
K011533 · LZO
Orthopedic · 255d
Cleared Dec 27, 2001
LONG TROCHANTERIC NAIL SYSTEM
K013563 · HSB
Orthopedic · 62d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · JDI
Orthopedic · 69d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · HSB
Orthopedic · 62d

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