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Orthopedic

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

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RecordFirmDate
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE (K970423)Innovasive Devices, Inc.1997-04-30
PEGGED ACETABULAR COMPONENT (K970501)Biomet, Inc.1997-04-30
TITANIUM ALLOY BONE SCREWS (K970549)Aesculap, Inc.1997-04-30
ALPHATEC EXTERNAL FIXATION SYSTEM (K964400)Alphatec Mfg., Inc.1997-04-28
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM (K970697)Osteonics Corp.1997-04-24
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW (K970292)Influence, Inc.1997-04-23
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM (K970394)Osteonics Corp.1997-04-22
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM (K964254)Sofamor Danek USA,Inc.1997-04-21
ARTOS, DIPLOS SYSTEM (K970284)Turnkey Intergration USA, Inc.1997-04-21
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM (K970897)Biodynamic Technologies, Inc.1997-04-21
INNOVASIVE 8MM LIGAMENT FASTENER (K970316)Innovasive Devices, Inc.1997-04-16
HEIDELBERG EXTERNAL FIXATOR (K970751)Smith & Nephew, Inc., Orthopaedic Div.1997-04-16
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT (K970194)Stelkast Company1997-04-14
EBI SPINELINK SYSTEM (K964533)Electro-Biology, Inc.1997-04-09
RELIANCE PF FEMORAL STEMS (K970200)Howmedica Corp.1997-04-09
NATURAL-HIP SYSTEM COCR REVISION STEM (K970166)Intermedics Orthopedics1997-04-08
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM (K970462)Acromed Corp.1997-04-03
ATLAS III ACETABULAR CUP (K961388)Fournitures Hospitalieres1997-04-03
COMPASS UNIVERSAL HINGE (K970713)Smith & Nephew, Inc., Orthopaedic Div.1997-04-03
BIOMET BONE SCREW (K964970)Biomet, Inc.1997-04-03
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY (K961260)Biomet, Inc.1997-04-02
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT (K970031)Encore Orthopedics, Inc.1997-04-02
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM (K970733)Synthes (Usa)1997-04-02
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM (K970290)Ebi, L.P.1997-04-01
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM (K964024)Depuy, Inc.1997-03-26
BACFIX SPINAL FIXATION SYSTEM (K964404)Spinal Concepts, Inc.1997-03-26
FIXATION PIN OR ROD (K970036)United States Surgical, A Division of Tyco Healthc1997-03-25
THE C-FIT FEMORAL HIP SYSTEM (K965019)Corin USA1997-03-25
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM (K963325)Synthes (Usa)1997-03-25
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER (K970089)Innovasive Devices, Inc.1997-03-25
AVANTA ORTHOPAEDICS TENDON SPACER (K964359)Avanta Orthopaedics, Inc.1997-03-25
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) (K963587)Wrightmedicaltechnologyinc1997-03-24
METAGEN ALL POLY ACETABULAR CUP SYSTEM (K964003)Metagen, LLC1997-03-21
DEPUY ACE AIM TITANIUM TIBIAL NAIL (K970202)Depuy Ace Medical Co.1997-03-21
MOSS MIAMI SPINAL SYSTEM (K962628)Depuy, Inc.1997-03-18
ACUMED SUTURE WASHER (K965028)Acu Med, Inc.1997-03-17
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM (K964416)Synthes (Usa)1997-03-17
LIBERTY ANTERIOR SPINAL SYSTEM (K965193)Sofamor Danek USA,Inc.1997-03-17
KIRSCHNER KNEE MODIFIED (K961021)Biomet, Inc.1997-03-17
ISOLA TWISTER CONNECTOR (K965046)Acromed Corp.1997-03-14
HOWMEDICA MAINSTAY ANCHOR (K965175)Howmedica Corp.1997-03-13
LINK CERCLAGE WIRE SYSTEM (K970084)Turnkey Intergration USA, Inc.1997-03-13
IMPLEX REPLACEMENT ACETABULAR CUP INSERT (K964882)Implex Corp.1997-03-13
BIORIGID NAIL TIBIA (K970013)Aap GmbH and Co. Betriebs KG1997-03-13
PROXIMAL FEMORAL NAIL (PFN) SYSTEM (K970097)Synthes (Usa)1997-03-13
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM (K965145)Depuy, Inc.1997-03-13
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR (K965164)Howmedica Corp.1997-03-13
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM (K961360)Encore Orthopedics, Inc.1997-03-13
MITEK SUTURE RETROGRADER (K970360)Mitek Products1997-03-10
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) (K964924)Osteoimplant Technology, Inc.1997-03-07
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY (K970055)KARL STORZ Endoscopy-America, Inc.1997-03-05
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM (K964879)Davol Inc., Sub. C. R. Bard, Inc.1997-03-04
GLOBAL TAPER SPECTRON HIP STEMS (K970351)Smith & Nephew, Inc., Orthopaedic Div.1997-02-28
INTRAMEDULLARY NAIL SYSTEM (K965098)Zimmer, Inc.1997-02-28
HANSSON PIN SYSTEM (K964893)Osteonics Corp.1997-02-28
HA GLOBAL TAPER (GT) TAPERED HIP STEM (K970337)Smith & Nephew, Inc., Orthopaedic Div.1997-02-28
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW (K965073)Smith & Nephew, Inc.1997-02-27
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (K970567)Intermedics Orthopedics1997-02-27
INNOVASIVE DEVICES ROTATOR CUFF FASTNER (K964945)Innovasive Devices, Inc.1997-02-24
KINEMAX PLUS TIBIAL SPACERS (K964951)Howmedica Corp.1997-02-24
COHORT DISCECTOMY SYSTEMS (CDS) (K964975)Cohort Medical Products Group, Inc.1997-02-24
MITEK ABSORBABLE TOGGLE ANCHOR (K964013)Mitek Products1997-02-24
CEMENTED CALCAR REPLACEMENT FEMORAL STEM (K964795)Johnson & Johnson Professionals, Inc.1997-02-19
PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT (K970346)Kairos Orthopaedics1997-02-19
ANTERIOR DYNAMIZED SYSTEM (K953978)Acromed Corp.1997-02-19
STABLELOC II EXTERNAL FIXATOR (K965029)Acu Med, Inc.1997-02-19
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 (K965111)R. Thomas Grotz, M.D., Inc.1997-02-18
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS (K964769)Zimmer, Inc.1997-02-13
NEXGEN COMPLETE KNEE SOLUTION (K963148)Zimmer, Inc.1997-02-13
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM (K963045)Synthes (Usa)1997-02-13
IN-TAC BONE ANCHOR SYSTEM (K964953)Influence, Inc.1997-02-13
B-P HEMISPHERICAL ACETABULAR COMPONENT (K963101)Endotec, Inc.1997-02-12
METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM (K963700)Metagen, LLC1997-02-12
ANSPACH SUTURE ANCHOR (K965069)The Anspach Effort, Inc.1997-02-12
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP (K963100)Endotec, Inc.1997-02-12
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY (K964544)Osteonics Corp.1997-02-11
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 (K964927)R. Thomas Grotz, M.D., Inc.1997-02-07
TITANIUM CD HORIZON SPINAL SYSTEM (K962708)Sofamor Danek USA,Inc.1997-02-06
LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS (K963741)Howmedica Leibinger, Inc.1997-02-06
DEPUY DUPONT PHANTOM SUTURE ANCHOR (K964521)Depuy, Inc.1997-02-06
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM (K964623)Sofamor Danek USA,Inc.1997-02-06
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM (K964786)Wrightmedicaltechnologyinc1997-02-06
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE (K964655)Howmedica Corp.1997-02-06
METALLIC SPHERICAL CMC IMPLANT (K960534)Wrightmedicaltechnologyinc1997-02-06
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.) (K961498)Howmedica, Inc.1997-02-06
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) (K960659)Wrightmedicaltechnologyinc1997-02-06
HEDROCEL ACETABULAR RESTRICTOR (K962468)Implex Corp.1997-02-03
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (K964933)Mekanika, Inc.1997-02-03
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (K964472)Biologically Oriented Prostheses1997-02-03
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP (K963671)Osteonics Corp.1997-02-03
MULTITAK SS SUTURE SYSTEM (K964532)Bonutti Research1997-02-03
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM (K964919)Emerald Medical, Inc.1997-01-28
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (K963509)Smith & Nephew Richards, Inc.1997-01-27
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) (K963946)Osteonics Corp.1997-01-27
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT (K964395)Hayes Medical, Inc.1997-01-27
METAL BACKED ACETABULAR COMPONENT (K963998)Encore Orthopedics, Inc.1997-01-27
NATURAL-HIP SYSTEM COCR STEM (K964357)Intermedics Orthopedics1997-01-27
DYNAMOMETER (K964685)John Chatillon & Sons, Inc.1997-01-27
FINN ROD TO ROD CONNECTOR (K960444)Smith & Nephew Richards, Inc.1997-01-24
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES (K965156)Johnson & Johnson Professionals, Inc.1997-01-24
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