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
126-150 of 198
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 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
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · KTT
Orthopedic · 25d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · MQV
Orthopedic · 221d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · JDI
Orthopedic · 29d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364 · LPH
Orthopedic · 85d
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · LPH
Orthopedic · 77d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · MBF
Orthopedic · 86d
Cleared Jun 28, 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · MBF
Orthopedic · 83d

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