FDA 510(k) Applications Submitted by THOMAS L CRAIG

FDA 510(k) Number Submission Date Device Name Applicant
K921195 03/12/1992 NASAL SEPTAL SPLINT SMITH & NEPHEW RICHARDS, INC.
K921199 03/12/1992 EPISTAXIS NASAL BALLOON CATHETER SMITH & NEPHEW RICHARDS, INC.
K921202 03/12/1992 TURBINATE NASAL SPLINT SMITH & NEPHEW RICHARDS, INC.
K921433 03/25/1992 ATTIC DEFECT PLATE SMITH & NEPHEW RICHARDS, INC.
K932755 05/21/1993 REFLECTION ACETABULAR COMPONENT SMITH & NEPHEW RICHARDS, INC.
K932574 05/27/1993 RMHS POROUS DISTAL SLEEVE SMITH & NEPHEW RICHARDS, INC.
K895121 08/15/1989 INTERMEDICS POWER BROACH IMPACTOR INTERMEDICS ORTHOPEDICS
K873679 09/14/1987 SELECT SHOULDER SYSTEM INTERMEDICS ORTHOPEDICS
K914343 09/27/1991 TI-FIT FEMORAL COMPONENT SMITH & NEPHEW RICHARDS, INC.
K930108 01/11/1993 RMHS POROUS DISTAL SLEEVE SMITH & NEPHEW RICHARDS, INC.
K930480 01/29/1993 VARIABLE ANGULAR HOLD BONE PLATE SYSTEM SMITH & NEPHEW RICHARDS, INC.
K970337 01/29/1997 HA GLOBAL TAPER (GT) TAPERED HIP STEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K890450 01/30/1989 INTERMEDICS APR(TM) II FEMORAL COMPONENT INTERMEDICS ORTHOPEDICS
K970351 01/30/1997 GLOBAL TAPER SPECTRON HIP STEMS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K950394 02/01/1995 TIBIA-TALUS-CALCANEUS NAIL SMITH & NEPHEW RICHARDS, INC.
K960444 02/01/1996 FINN ROD TO ROD CONNECTOR SMITH & NEPHEW RICHARDS, INC.
K920430 02/03/1992 MODULAR ACETABULAR CUP SYSTEM SMITH & NEPHEW RICHARDS, INC.
K910755 02/15/1991 PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING INTERMEDICS ORTHOPEDICS
K930788 02/16/1993 ZIRCONIA CERAMIC FEMORAL HEAD SMITH & NEPHEW RICHARDS, INC.
K850770 02/25/1985 INTERMEDICS BONE SCREW INTERMEDICS ORTHOPEDICS
K850793 02/26/1985 MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA INTERMEDICS ORTHOPEDICS
K910920 03/05/1991 PROTEKT GLOVES INTERMEDICS ORTHOPEDICS
K931131 03/05/1993 THE RICHARDS WRIST SMITH & NEPHEW RICHARDS, INC.
K901085 03/09/1990 DORR KNEE SYSTEM INTERMEDICS ORTHOPEDICS
K921400 03/24/1992 HIP JOINT PROTHESIS SMITH & NEPHEW RICHARDS, INC.
K931642 04/02/1993 RMHS MONOLITHIC FEMORAL COMPONENT SMITH & NEPHEW RICHARDS, INC.
K892228 04/05/1989 INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM INTERMEDICS ORTHOPEDICS
K921786 04/14/1992 INTRAMEDULLARY HIP SCREW SMITH & NEPHEW RICHARDS, INC.
K951987 04/27/1995 GENESIS II TOTAL KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC.
K881836 05/02/1988 INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP INTERMEDICS ORTHOPEDICS
K952271 05/15/1995 GENESIS CONSTRAINED SYSTEM (GCS) SMITH & NEPHEW RICHARDS, INC.
K902335 05/24/1990 NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM) INTERMEDICS ORTHOPEDICS
K922621 06/03/1992 HA TI-FIT ACETABULAR AND FEMORAL COMPONENT SMITH & NEPHEW RICHARDS, INC.
K962137 06/03/1996 GENESIS II CONSTRAINED SYSTEM SMITH & NEPHEW RICHARDS, INC.
K894051 06/07/1989 PREMIER-TOTAL HIP INTERMEDICS ORTHOPEDICS
K942760 06/13/1994 PNEUMATIC WIRE TENSIONER SMITH & NEPHEW RICHARDS, INC.
K933027 06/22/1993 THE MODULAR NAIL SMITH & NEPHEW RICHARDS, INC.
K962557 07/01/1996 GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT SMITH & NEPHEW RICHARDS, INC.
K923275 07/06/1992 RMHS MONOLITHIC FEMORAL COMPONENT SMITH & NEPHEW RICHARDS, INC.
K953274 07/14/1995 GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC.
K962784 07/17/1996 ULTIUM SPINAL PLATING SYSTEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K962808 07/18/1996 ILIZAROV EXTERNAL FIXATION SYSTEM SMITH & NEPHEW RICHARDS, INC.
K842893 07/23/1984 DORR HIP PROSTHESIS, ACETABULAR COMPON CARBOMEDICS, INC.
K853169 07/30/1985 GT HIP PROSTHESIS FEMORAL COMPONENT INTERMEDICS ORTHOPEDICS
K933958 08/13/1993 RICHARDS TOTAL KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC.
K924141 08/18/1992 ORTHOPAEDIC POLYETHYLENE CABLE SMITH & NEPHEW RICHARDS, INC.
K963255 08/19/1996 PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K853524 08/22/1985 APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT INTERMEDICS ORTHOPEDICS
K963486 09/03/1996 REVISION HIP SYSTEM SMITH & NEPHEW RICHARDS, INC.
K963509 09/03/1996 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON SMITH & NEPHEW RICHARDS, INC.
K873602 09/04/1987 INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM INTERMEDICS ORTHOPEDICS
K934353 09/08/1993 ZIRCONIUM ALLOY UNI-POLAR HEAD SMITH & NEPHEW RICHARDS, INC.
K934431 09/13/1993 PNEUMATIC WIRE TENSIONER SMITH & NEPHEW RICHARDS, INC.
K883969 09/20/1988 UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM INTERMEDICS ORTHOPEDICS
K873815 09/21/1987 IOI BIPOLAR PROSTHESIS INTERMEDICS ORTHOPEDICS
K934590 09/24/1993 IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS SMITH & NEPHEW RICHARDS, INC.
K853991 09/27/1985 HOFMANN KNEE INTERMEDICS ORTHOPEDICS
K873999 10/01/1987 PREMIER-TOTAL (TM) HIP INTERMEDICS ORTHOPEDICS
K964163 10/17/1996 TRIMAX NAIL SYSTEM SMITH & NEPHEW RICHARDS, INC.
K954909 10/25/1995 PROFIX POSTERIOR-STABILIZED KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC.
K935921 11/17/1993 ZIRCONIA CERAMIC FEMORAL HEAD SMITH & NEPHEW RICHARDS, INC.
K905260 11/21/1990 TOTAL HIP FEMORAL COMPONENT INTERMEDICS ORTHOPEDICS
K884943 11/25/1988 INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID INTERMEDICS ORTHOPEDICS
K946088 12/13/1994 GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM SMITH & NEPHEW RICHARDS, INC.
K885192 12/16/1988 APR COLLARED REVISION FEMORAL COMPONENT INTERMEDICS ORTHOPEDICS
K955767 12/21/1995 COFIED MODULAR SHOULDER SYSTEM SMITH & NEPHEW RICHARDS, INC.
K946236 12/22/1994 PROFIX CONFORMING PLUS TIBIAL INSERT SMITH & NEPHEW RICHARDS, INC.
K905781 12/28/1990 APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM INTERMEDICS ORTHOPEDICS
K936233 12/29/1993 PELVIC RADIUS PLATE SMITH & NEPHEW RICHARDS, INC.
K965224 12/30/1996 EMPOWER ANTERIOR DIRECT SCREWS SMITH & NEPHEW RICHARDS, INC.


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