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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT (K912663)Intermedics Orthopedics1991-09-16
DANEK SACRAL HOOK, MODIFICATION (K911379)Danek Medical, Inc.1991-09-11
T-BOLT AND NUT (K911306)Danek Medical, Inc.1991-09-10
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY (K910940)Depuy, Inc.1991-09-10
MAY HUMERUS PLATES (K912936)Turnkey Intergration USA, Inc.1991-09-06
TSRH OPEN HEAD BONE SCREW (K911319)Danek Medical, Inc.1991-09-06
MASTERPIECES(TM)/MICRO/MINI SYSTEMS (K913289)Storz Instrument Co.1991-09-05
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) (K904446)Acromed Corp.1991-09-05
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM (K912526)J-Tech, Inc.1991-09-05
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (K912190)Stryker Corp.1991-08-29
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC (K912263)Zimmer, Inc.1991-08-29
INTELIJET TM FLUID MANAGEMENT SYSTEM (K912453)Smith & Nephew Dyonics, Inc.1991-08-26
P.F.C. UNICONDYLAR KNEE SYSTEM (K910968)Johnson & Johnson Orthopaedics, Inc.1991-08-26
HUENE FIXATION SCREW (K910193)Acu-Med, Inc.1991-08-23
UHMWP ACETABULAR COMPONENT (K912426)Howmedica Corp.1991-08-21
MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP (K912266)Orothmet, Inc.1991-08-20
AGC REVISION KNEE PROTHESIS (K912245)Biomet, Inc.1991-08-19
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO (K912205)Microaire1991-08-16
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP (K912654)Osteonics Corp.1991-08-16
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO. (K912206)Microaire1991-08-16
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C (K911728)Osteonics Corp.1991-08-16
INTRAMEDULLARY HIP SCREW, MODIFICATION (K912162)Smith & Nephew Richards, Inc.1991-08-14
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP (K912147)Osteonics Corp.1991-08-13
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL (K912295)Kinamed, Inc.1991-08-12
INSIDE JOB (K912871)3M Health Care, Ltd.1991-08-09
ALTA CHANNEL PLATE CONNECTOR (K910482)Howmedica Corp.1991-07-30
FINN KNEE PROSTHESIS (K910877)Biomet, Inc.1991-07-26
OSTEONICS(R) PRT HIP STEM SERIES (K911890)Osteonics Corp.1991-07-26
MASTERPIECES MICRO SYSTEM (K910957)Storz Instrument Co.1991-07-26
GROSS HIP FEMORAL COMPONENT (K904737)Johnson & Johnson Orthopaedics, Inc.1991-07-26
BONE NAIL, KUNTSCHER (K911982)International Hospital Supply Co.1991-07-26
WYMAN SUTURE WASHER (K910186)Acu Med, Inc.1991-07-25
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT (K912395)Howmedica Corp.1991-07-24
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER (K910229)Depuy, Inc.1991-07-24
K-CAP-I, STERILE (K912762)Westcon Orthopedics, Inc.1991-07-18
TOWNLEY TOTAL KNEE (TTK) (K904448)Biopro, Inc.1991-07-17
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) (K911718)Biomet, Inc.1991-07-16
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL (K911686)Depuy, Inc.1991-07-15
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP (K911685)Biomet, Inc.1991-07-15
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE (K911595)Dow Corning Wright1991-07-12
FX-CABLELOK SYSTEM (K912207)Biodynamic Technologies, Inc.1991-07-09
AIM TIBIAL NAIL (K911554)Ace Medical Co.1991-07-08
BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS (K912108)Microaire Advanced Surgical Products1991-07-02
OMNIFIT II EPF HIP STEM SERIES (K911585)Osteonics Corp.1991-07-01
FUTURA FEMORAL HIP STEM (K910093)O'Tec Corp.1991-07-01
MG II POROUS COBAL T-CHROME FEMORAL COMPONENT (K911572)Zimmer, Inc.1991-07-01
UNIVERSAL COMPRESSION SCREW (K904809)Howmedica Corp.1991-06-28
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW (K911528)Acromed Corp.1991-06-28
TEMPERLITE(TM) SAW BLADE (K911902)Sierra Surgical, Inc.1991-06-28
ACRYL-X SYSTEM TM (K911548)Sonokinetics, Inc.1991-06-28
FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM (K911445)Neoligaments, Ltd.1991-06-28
BIOMET COBALT-CHROME FEMORAL COMPONENTS (K911684)Biomet, Inc.1991-06-27
KEANE UNI KNEE SYSTEM (K910807)Depuy, Inc.1991-06-27
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM (K911398)Howmedica Corp.1991-06-27
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP (K911373)Osteonics Corp.1991-06-26
MTS KNEE SYSTEM (K905613)T & R Mfg., Inc.1991-06-24
TMP MANDIBULAR COMPRESSION SYSTEM (K905024)Techmedica, Inc.1991-06-24
PCA MTK II TOTAL KNEE SYSTEM (K910235)Howmedica Corp.1991-06-21
ISOLA(TM) SPINE SYSTEM--EYE ROD (K911394)Acromed Corp.1991-06-21
FIXATION DEVICES AND BONE PLATE (K910175)Micro Surgical Instruments Corp.1991-06-21
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS (K910990)Osteonics Corp.1991-06-19
LEVTECH TITANIUM BONE WIRE (K910128)Levtech, Inc.1991-06-18
NEXUS(TM) FEMORAL HIP STEM (K911052)Dow Corning Wright1991-06-17
TITAN TOTAL HIP DEVICE (K905298)Dr. Jean-Marc Guichet1991-06-17
ARTHROSCOPY INSTRUMENT CANNULA (K911205)Davol, Inc.1991-06-17
LIMA COLLARED CL STEM (K910836)Lima Intl. Corp.1991-06-14
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP (K910352)Biopro, Inc.1991-06-13
THACKRAY TITANIUM MINI-PLATING SYSTEM (K905774)Depuy, Inc.1991-06-13
NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION (K905810)Joint Medical Products Corp.1991-06-12
HYDROXYAPATITE COATED PROFILE(R) HIP STEM (K910156)Depuy, Inc.1991-06-07
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP (K910989)Osteonics Corp.1991-06-05
LIGAMENTOPLASTIC STAPLE OF L'UNION (K911020)Sport Service, Inc.1991-05-29
DCW MODULAR DISTAL FEMORAL SYSTEM (K910596)Dow Corning Wright1991-05-29
PLATE BLADE WITH CURSOR OF L'UNION (K911021)Sport Service, Inc.1991-05-29
SGARLATO FLEXIBLE HINGE TOE IMPLANT (K905795)Sgarlato Laboratories, Inc.1991-05-29
STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION (K911026)Sport Service, Inc.1991-05-29
THE TRAMOND PIN (K911031)Sport Service, Inc.1991-05-29
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL (K910563)Johnson & Johnson Orthopaedics, Inc.1991-05-23
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY (K911198)Orthomet, Inc.1991-05-23
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON (K904870)Endotec, Inc.1991-05-23
HOWMEDICA(R) CEMETED FEMORAL COMPONENT (K910869)Howmedica Corp.1991-05-23
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM (K911197)Orthomet, Inc.1991-05-23
STRYKER ARTHROSCOPIC INFUSION PUMP (K910858)Stryker Corp.1991-05-23
S-ROM OBLONG ACETABULAR CUP (K905258)Joint Medical Products Corp.1991-05-21
PS OMNIFIT NORMALIZED HIP STEM SERIES (K910662)Osteonics Corp.1991-05-13
MINISCOPE (K910587)Citation Medical Corp.1991-05-13
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM (K910500)Howmedica Corp.1991-05-06
ZIRCONIA CERAMIC MODULAR HEADS (K905687)Biomet, Inc.1991-04-15
FIXATION PIN (K911452)Simpex, Inc.1991-04-12
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) (K910547)Turnkey Intergration USA, Inc.1991-04-12
FLEXMEDICS MALLEABLE CANNULA (K910674)Flexmedics1991-04-12
FIXATION WIRE (K911505)Simpex, Inc.1991-04-12
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) (K910548)Turnkey Intergration USA, Inc.1991-04-09
MICROSURGICAL INSTRUMENTS (K911300)Danek Medical, Inc.1991-04-05
OSTEONICS CDH HIP STEM (K910922)Osteonics Corp.1991-04-05
AUTOGENESIS(TM) AUTOMATOR (K905514)Advanced Biosearch Assn.1991-04-02
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM (K904208)Howmedica Corp.1991-04-01
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES (K910083)Osteonics Corp.1991-04-01
AMSET PLD SYSTEM (K905014)Advanced Med/Surg, Inc.1991-04-01
ORTHOCONCEPT ARTHROSCOPIC PUMP (K910164)Orthoconcept, Inc.1991-03-27
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