FDA 510(k) Applications Submitted by JANE E JOHNSON
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K972562 |
07/09/1997 |
BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED |
ELECTROSCOPE, INC. |
K973682 |
09/26/1997 |
BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, |
ELECTROSCOPE, INC. |
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. |
K961578 |
04/24/1996 |
SUTURE ANCHOR |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
K961585 |
04/24/1996 |
SURGICAL DYNAMICS POP RIVET |
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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