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HWC

1,062 FDA 510(k) clearances · Product code

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RecordFirmDate
METASURG SUBTALAR IMPLANT (K111265)Metasurg2011-08-09
N-FORCE FIXATION SYSTEM (K102528)Innovision, Inc.2011-07-28
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR (K111000)Parcus Medical, LLC2011-07-28
3.7MM/5.0MM DYNAMIC LOCKING SCREW (K110592)Synthes USA2011-07-25
METASURG DIGIFUSE IMPLANT (K111536)Metasurg2011-07-21
AAP CANNULATED SCREWS (K111316)Aap Implantate AG2011-07-20
PRO FIXATION SYSTEM (K110538)Synovis Orthopedic & Woundcare2011-07-12
APTUS CANNULATED COMPRESSION SCREWS (K110658)Medartis AG2011-06-02
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW (K111230)Synthes (USA) Products, LLC2011-05-24
STERILE STORM (R) OPERATING KIT (K111001)Intelligent Orthopaedics, Ltd.2011-05-17
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM (K102324)Wrightmedicaltechnologyinc2011-05-04
LATARJET CORTICAL SCREW SET (K110763)T.A.G. Medical Products Corporation, Ltd.2011-04-11
LOW PROFILE SCREWS (K103705)Arthrex, Inc.2011-03-18
FLEXFUSION (TM) FIXATION IMPLANT (K110445)Nextremity Solutions, LLC2011-03-17
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD (K103712)Depuy Mitek, A Johnson & Johnson Company2011-03-11
TRILLIANT SURGICAL SUBTALAR IMPLANT (K103183)Trilliant Surgical, Ltd.2011-02-08
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND (K102298)Depuy Mitek, A Johnson & Johnson Company2011-01-07
MATRYX INTERFERENCE SCREW (5.0-6.5MM) (K102410)Conmed Linvatec2010-12-21
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM (K102343)Emerge Medical2010-11-23
LOCKING BONE SCREW MODEL HCQ04, HCZ04 (K100721)Changzhou Orthmar Medical Instrument Co., Ltd.2010-11-23
CSTS SCREW (K093055)Orthopro, LLC2010-11-22
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR (K102326)Parcus Medical, LLC2010-11-15
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR (K102162)Parcus Medical, LLC2010-11-10
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER (K101808)Medshape Solutions2010-11-08
PIONEER CANNULATED SCREW SYSTEM (K102903)Pioneer Surgical Technology, Inc.2010-10-20
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM (K101700)Extremity Medical, LLC2010-10-12
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM (K101696)Zimmer, Inc.2010-09-10
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM (K101165)Wrightmedicaltechnologyinc2010-07-23
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM (K101254)Tecnologia Y Diseno Industrial, S.A DE C.V2010-07-15
DARCO HEADED CANNULATED SCREW (K100359)Wrightmedicaltechnologyinc2010-06-24
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS (K093078)Bonutti Research, Inc.2010-06-23
MODIFICATION TO HBS HEADLESS BONE SCREW (K101030)Biopro, Inc.2010-06-03
SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (K093820)Memometal Technologies2010-05-19
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES (K100325)Smith & Nephew, Inc.2010-05-04
EXTREMITY MEDICAL SCREW SYSTEM (K093770)Extremity Medical, LLC2010-04-28
OPUS SPEEDSCREW SYSTEM (K100457)Arthrocare Corp.2010-03-19
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 (K100532)Depuy Mitek, A Johnson & Johnson Company2010-03-17
OMNITECH LARGE, TRIMED COMPRESSION SCREW (K093676)TriMed, Inc.2010-03-17
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 (K092754)Small Bone Innovations, Inc.2010-01-19
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) (K092909)Synthes (Usa)2010-01-11
FOOT AND HAND MOTION SYSTEM (K091118)Newclip Technics2009-12-16
LEFORTE NEUROSYSTEM BONE SCREW (K091686)Jeil Medical Corporation2009-11-13
ASCENSION CANNULATED SCREW SYSTEM (K092440)Ascension Orthopedics, Inc.2009-11-05
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N (K092133)Arthrocare Corp.2009-11-05
SYNERGY CANNULATED SCREW SYSTEM (K092082)Synergy Surgical Technologies, LLC2009-10-02
PARCUS PPEK CF INTERFERENCE SCREW (K091093)Parcus Medical, LLC2009-09-30
POGO SCREW (K092189)Fxdevices2009-09-18
WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, (K091202)Medshape Solutions2009-09-16
UNITY BETA PLLA SYSTEM (K090175)Bonutti Research, Inc.2009-09-10
MERETE COMPRESSION SCREWS (K091798)Merete Medical GmbH2009-09-02
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS (K090949)Synthes (Usa)2009-07-31
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM (K091577)Extremity Medical, LLC2009-07-24
TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS (K083912)Treu-Instrumente GmbH2009-07-15
MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) (K091694)Tag Medical Products2009-07-07
INTERTAN CHS LIMITED COLLAPSE SET SCREW (K090656)Smith & Nephew, Inc.2009-06-03
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT (K091069)Medacta International S.A.2009-06-01
FUSION MEDICAL CANNULATED SCREW SYSTEM (K081122)John Riccio2009-05-26
FUSION MEDICAL STI (K081755)John Riccio2009-05-20
LIGAFIX INTERFACE SCREW (K090994)Science For Biomaterials2009-05-06
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM (K082934)Extremity Medical, LLC2009-04-23
LATARJET CORTICAL SCREW SET (K083096)Tag Medical Products2009-04-17
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 (K083792)Medshape Solutions2009-03-25
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM (K081813)U.S. Implant Solutions, LLC2009-03-12
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 (K083619)Parcus Medical, LLC2009-03-06
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM (K083612)Cayenne Medical, Inc.2009-03-04
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM (K083607)Cayenne Medical, Inc.2009-03-04
BIODRIVE CANNULATED SCREW SYSTEM (K082874)Biomet Trauma2009-02-05
MAXTORQUE MINI CANNULATED SCREW SYSTEM (K082574)Orthohelix Surgical Designs, Inc.2008-12-08
ORTHOPEDIATRICS BONE SCREWS (K082949)OrthoPediatrics Corp.2008-11-25
POGO SCREW (K080649)Fxdevices2008-11-25
HEALIX TI ANCHOR (K082282)Depuy Mitek, A Johnson & Johnson Co.2008-11-07
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (K081011)Arex USA2008-11-07
DARCO SMALL SCREW (K082320)Wrightmedicaltechnologyinc2008-11-05
UNITY BETA ANCHOR SYSTEM (K082906)Bonutti Research, Inc.2008-10-30
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 (K081893)Arthrocare Corp.2008-10-01
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS (K082516)Smith & Nephew, Inc.2008-09-17
EXTREMITY MEDICAL COMPRESSION SCREW (K081934)Extremity Medical, LLC2008-08-29
JMEA CANNULATED BONE SCREW SYSTEM (K080259)Jmea Corporation2008-08-20
BIOACTIF OSTEOTRANS INTERFENCE SCREW (K081390)Takiron Co., Ltd.2008-08-12
BIOPRO GO-EZ SCREW (K081149)Biopro, Inc.2008-08-05
TIGER CANNULATED SCREW SYSTEM (K081510)Trilliant Surgical, Ltd.2008-08-04
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 (K073159)Trauson (Jiangsu) Medical Instrument Co., Ltd.2008-07-23
MERETE 3.0 AND 3.5 MM LOCKING SCREWS (K081513)Merete Medical GmbH2008-07-18
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION (K081700)Synthes (Usa)2008-07-17
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR (K072291)Conmed Linvatec2008-07-14
ENSPLINT TM BONE SCREW (K080778)Sonoma Orthopedic Products, Inc.2008-07-10
TLS FIXATION SYSTEM (K080974)Fournitures Hospitalieres Industrie2008-07-01
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR (K081428)Biocomposites, Ltd.2008-06-20
BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN (K081392)Bioretec, Ltd.2008-06-18
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS (K080088)Biomet Manufacturing, Inc.2008-06-11
OSTEOTRANS-OT SCREW (K073312)Takiron Co., Ltd.2008-05-13
SYNTHES 6.5MM MIDFOOT FUSION BOLT (K081071)Synthes (Usa)2008-05-01
PLLA, HA SCREW (K080358)Smith & Nephew Inc., Endoscopy Div.2008-04-23
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS (K080943)Synthes (Usa)2008-04-23
DARCO HEADLESS COMPRESSION SCREW (K080850)Wrightmedicaltechnologyinc2008-04-10
AAP CANNULATED SCREW AND DARCO HEADED SCREW (K080101)Aap Implantate AG2008-03-25
SUB-TALAR LOK, MODEL 7-11 MM (K080280)Instratek, Inc.2008-03-14
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE (K080352)Depuy Mitek, A Johnson & Johnson Company2008-03-12
TWINFIX PK FP SUTURE ANCHOR (K073509)Smith & Nephew, Inc.2008-03-04
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM (K073426)Cayenne Medical, Inc.2008-02-19
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