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KWS

191 FDA 510(k) clearances · Product code

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RecordFirmDate
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM (K103419)Exactech, Inc.2010-12-13
ARROW ANATOMICAL SHOULDER SYSTEM (K093599)Fournitures Hospitalieres Industrie2010-11-24
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT (K103104)Howmedica Osteonics Corp.2010-11-22
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM (K103007)Tornier, Inc.2010-11-09
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. (K093430)Exactech, Inc.2010-09-02
ASCENSION MODULAR TOTAL SHOULDER SYSTEM (K100448)Ascension Orthopedics, Inc.2010-08-30
GRS GLENOID RESURFACING SYSTEM (K091196)Arthrosurface, Inc.2009-10-27
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID (K092122)DePuy Orthopaedics, Inc.2009-07-27
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP (K091751)DePuy Orthopaedics, Inc.2009-07-14
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID (K083435)Arthrex, Inc.2009-06-26
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS (K082120)Tornier2008-10-24
AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS (K081707)Tornier, Inc.2008-07-17
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM (K081620)DePuy Orthopaedics, Inc.2008-06-30
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 (K080402)Encore Medical L.P.2008-03-28
ARTHREX UNIVERS II SHOULDER PROSTHESIS (K071032)Arthrex, Inc.2007-08-20
TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION (K071090)Zimmer Trabecular Metal Technology2007-06-29
MODULAR HYBRID GLENOID (K060694)Biomet Manufacturing Corp2006-12-11
TOTAL AND HEMI SHOULDER SYSTEM (K060988)Dvo Extremity Solutions, LLC2006-12-06
ANATOMICAL SHOULDER FRACTURE SYSTEM (K062029)Zimmer GmbH2006-10-31
SOLAR REUNION FRACTURE STEM (K062113)Howmedica Osteonics Corp.2006-10-03
DEPUY GLOBAL AP SHOULDER SYSTEM (K060874)DePuy Orthopaedics, Inc.2006-06-28
AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM (K060209)Tornier2006-03-02
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID (K052472)DePuy Orthopaedics, Inc.2005-10-06
ANATOMICAL SHOULDER KEELED GLENOID (K051623)Zimmer GmbH2005-07-19
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 (K043346)Genesis Medical LLC2005-01-31
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM (K043077)Tornier2004-12-17
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX (K043061)Zimmer Trabecular2004-11-23
EXACTECH EQUINOXE SHOULDER SYSTEM (K042021)Exactech, Inc.2004-10-26
AEQUALIS SHOULDER SYSTEM (K041339)Tornier2004-06-17
VERSA-DIAL HUMERAL HEAD (K040610)Biomet Manufacturing, Inc.2004-06-04
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE (K033506)Biomet, Inc.2004-02-02
AEQUALIS SHOULDER FRACTURE SYSTEM (K032679)Tornier2003-12-15
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION (K031449)Implex Corp.2003-09-23
AMATOMICAL SHOULDER WITH REMOVABLE HEAD (K030259)Centerplus Orthopedics, Inc.2003-04-24
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS (K030344)Smith & Nephew, Inc.2003-03-04
ARTHREX UNIVERS FRACTURE PROSTHESIS (K020345)Arthrex, Inc.2002-09-06
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II (K012788)Smith & Nephew, Inc.2002-03-15
3D HUMERAL HEADS (K012378)Smith & Nephew, Inc.2001-12-13
PLASMA SPRAYED SHOULDER (K003324)Encore Orthopedics, Inc.2001-12-06
MODIFICATION TO AEQUALIS SHOULDER SYSTEM (K012212)Tornier2001-08-15
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS (K010124)Arthrex, Inc.2001-04-06
ANATOMICAL PRESS-FIT HUMERAL STEM (K003801)Sulzer Orthopedics, Inc.2001-02-28
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS (K003566)Smith & Nephew, Inc.2001-02-14
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM (K003832)Sulzer Orthopedics, Inc.2001-01-04
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM (K003728)Tornier2000-12-20
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM (K002683)Wrightmedicaltechnologyinc2000-11-22
WMT MODULAR SHOULDER SYSTEM (K001706)Wrightmedicaltechnologyinc2000-08-16
AEQUALIS UNIVERSAL SHOULDER GLENOID (K994393)Tornier2000-06-22
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS (K001046)Biopro, Inc.2000-06-08
NEER III TOTAL SHOULDER SYSTEM (K994350)Smith & Nephew, Inc.2000-05-23
AEQUALIS SHOULDER FRACTURE SYSTEM (K994392)Tornier2000-03-10
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD (K000575)DePuy Orthopaedics, Inc.2000-03-10
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS (K992899)Biomet, Inc.1999-10-21
BIO-MODULAR SHOULDER SYSTEM (K992119)Biomet, Inc.1999-09-13
AEQUALIS SHOULDER PROSTHESIS (K980244)Tornier1999-08-23
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD (K992065)DePuy Orthopaedics, Inc.1999-07-12
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD (K990598)Howmedica Osteonics Corp.1999-03-15
ANATOMICA GLENOID COMPONENT (K990136)Sulzer Orthopedics, Inc.1999-03-01
ANATOMICA HUMERAL STEM/HEAD COMPONENTS (K990137)Sulzer Orthopedics, Inc.1999-02-18
DEPUY GLOBAL SHOULDER GLENOID (K981487)DePuy Orthopaedics, Inc.1998-07-13
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD (K974044)DePuy Orthopaedics, Inc.1998-01-22
SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS (K971715)Sulzer Orthopedics, Inc.1997-08-07
SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS (K962224)Intermedics Orthopedics1996-08-28
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT (K962082)Osteonics Corp.1996-08-13
FOUNDATION GLENOID COMPONENT (K960906)Encore Orthopedics, Inc.1996-04-15
OSTEONICS N2/VAC PACKAGING PROCESS (K955944)Osteonics Corp.1996-04-09
COFIED MODULAR SHOULDER SYSTEM (K955767)Smith & Nephew Richards, Inc.1996-04-08
OSTEONICS SHOULDER HUMERAL COMPONENTS (K955731)Osteonics Corp.1996-03-05
AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS (K952928)Tornier1995-09-27
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT (K950521)Osteonics Corp.1995-06-16
TOTAL SHOULDER PROSTHESIS (K950651)Encore Orthopedics, Inc.1995-05-30
SELECT(R) SHOULDER ALL POLY GLENOID (K935802)Intermedics Orthopedics1995-05-22
DEPUY POROUS COATED GLOBAL SHOULDER (K943300)Depuy, Inc.1994-10-31
3M MODULAR SHOULDER SYSTEM (K920362)3M Health Care, Ltd.1993-07-22
BEUCHEL-PAPPAS GLENOID COMPONENT (K904879)Endotec, Inc.1991-01-28
BUECHEL-PAPPAS HUMERAL STEM COMPONENT (K904880)Endotec, Inc.1991-01-28
OSTEONICS SR GLENOID COMPONENTS (K903886)Osteonics Reconstructive Products Div.1990-11-20
NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT (K902855)Depuy, Inc.1990-09-20
PAPILLOTOME (K901434)Telemed Systems, Inc.1990-06-08
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS (K895226)3M Company1989-11-03
INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID (K884943)Intermedics Orthopedics1989-04-27
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS (K883816)Osteonics Corp.1988-11-10
NORMAL HUMERAL PROSTHESIS (K881750)Osteonics Corp.1988-08-30
INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP (K881836)Intermedics Orthopedics1988-08-29
FENLIN II SHOULDER PROSTHESIS (K870262)Zimmer, Inc.1987-04-03
OSTEONICS SHOULDER PROSTHESIS (K862535)Osteonics Corp.1986-09-02
COFIELD SHOULDER SYSTEM (K855183)Richards Medical Co., Inc.1986-03-26
LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM (K852365)Link America, Inc.1985-12-16
COFIELD SHOULDER SYSTEM (K843624)Richards Medical Co., Inc.1985-01-10
MONOSPHERICAL GLENOID PROSTH. KEEL (K833410)Howmedica Corp.1983-11-07
UCLA SHOULDER (K801970)Howmedica Corp.1980-12-31
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