FDA 510(k) Applications Submitted by JANET G JOHNSON

FDA 510(k) Number Submission Date Device Name Applicant
K961699 05/02/1996 EQUIPMENT COVERS UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K992065 06/18/1999 GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD DEPUY ORTHOPAEDICS, INC.
K023012 09/10/2002 SMARTSET HV BONE CEMENT DEPUY ORTHOPAEDICS, INC.
K965198 12/26/1996 ULTIMA TPS CEMENTED STEM JOHNSON & JOHNSON INTERNATIONAL
K042127 08/06/2004 SMITH & NEPHEW MODULAR HIP SMITH & NEPHEW, INC.
K032722 09/03/2003 TRIGEN STRAIGHT HUMERAL NAIL SYSTEM SMITH & NEPHEW, INC.
K042515 09/16/2004 SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE SMITH & NEPHEW, INC.
K033341 10/17/2003 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS SMITH & NEPHEW, INC.
K043052 11/05/2004 TRIGEN HINDFOOT FUSION NAIL SMITH & NEPHEW, INC.
K990666 03/02/1999 HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL SMITH & NEPHEW, INC.
K021803 06/03/2002 REFLECTION CONSTRAINED LINER SMITH & NEPHEW, INC.
K992220 07/01/1999 RADIAL HEAD PROSTHESIS SMITH & NEPHEW, INC.
K022676 08/12/2002 ORTHOGUARD AB ANTIMICROBIAL SLEEVE SMITH & NEPHEW, INC.
K993289 10/01/1999 SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM SMITH & NEPHEW, INC.
K013989 12/04/2001 ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER SMITH & NEPHEW, INC.
K032683 08/29/2003 GENESIS II POROUS PLUS HA KNEE SYSTEM SMITH & NEPHEW, INC.
K980286 01/26/1998 ULTIMA ACETABULAR ROOF REINFORCEMENT RING JOHNSON & JOHNSON PROFESSIONALS, INC.
K020541 02/19/2002 AGILITY ANKLE REVISION PROSTHESIS DEPUY, INC.
K960805 02/28/1996 ARTHOSCOPE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K010810 03/19/2001 DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC.
K991106 04/01/1999 P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY DEPUY ORTHOPAEDICS, INC.
K991135 04/05/1999 SOFT TISSUE SUTURE WASHER DEPUY, INC.
K961585 04/24/1996 SURGICAL DYNAMICS POP RIVET UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K961578 04/24/1996 SUTURE ANCHOR UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K021478 05/08/2002 DELTA SHOULDER DEPUY, INC.
K001451 05/09/2000 MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC.
K021499 05/09/2002 CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT DEPUY ORTHOPAEDICS, INC.
K961856 05/14/1996 AUTO SUTURE CHEMOSITE TUNNELER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K011810 06/11/2001 ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING DEPUY, INC.
K001922 06/23/2000 DEPUY NEUFLEX PIP FINGER DEPUY, INC.
K982379 07/08/1998 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER JOHNSON & JOHNSON PROFESSIONALS, INC.
K992656 08/09/1999 DEPUY TOTAL ELBOW SYSTEM DEPUY ORTHOPAEDICS, INC.
K963115 08/12/1996 TROCAR CANNULA UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K983014 08/28/1998 SUMMIT ACETABULAR SYSTEM JOHNSON & JOHNSON PROFESSIONALS, INC.
K023103 09/18/2002 DEPUY 1 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC.
K003026 09/28/2000 PFC SIGMA LUGGED TIBIAL TRAY DEPUY ORTHOPAEDICS, INC.
K062930 09/28/2006 LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM ALCON RESEARCH, LTD.
K973774 10/03/1997 CODMAN HAKIM MICRO PRECISION VALVE JOHNSON & JOHNSON PROFESSIONALS, INC.
K003182 10/11/2000 ORTHOGENESIS LPS SYSTEM DEPUY, INC.
K083107 10/20/2008 MODIFICATION TO DEPUY NEUFLEX PIP FINGER DEPUY ORTHOPAEDICS, INC.
K964581 11/15/1996 SOFSILK UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K974331 11/18/1997 UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM JOHNSON & JOHNSON PROFESSIONALS, INC.
K023743 11/07/2002 SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM SMITH & NEPHEW, INC.
K991538 05/03/1999 OPERA CUPFLANGED ACETABULAR COMPONENTS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.


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