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HRS

1,320 FDA 510(k) clearances · Product code

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RecordFirmDate
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG (K121495)Aap Implantate AG2012-12-07
CHECKMATE SMALL BONE FUSION SYSTEM (K122334)Arthrosurface, Inc.2012-11-28
MERETE LOCKING BONE PLATE SYSTEM III (K120787)Merete Medical GmbH2012-11-27
STABILIZ FIXATION SYSTEM (K120651)Stabiliz Orthopaedics, LLC2012-11-27
PICCOLO COMPOSITE PLATE SYSTEM (K120409)CarboFix Orthopedics , Ltd.2012-11-26
ACUMED PELVIC BONE PLATE SYSTEM (K122538)Acumed, LLC2012-11-19
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING (K121494)Aap Implantate AG2012-11-19
KLS MARTIN RECON TALON (K122860)KLS Martin L.P.2012-11-14
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM (K113601)Aap Implantate AG2012-11-08
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM (K113602)Aap Implantate AG2012-10-31
PIONEER STERNAL CABLE PLATE SYSTEM (K122293)Pioneer Surgical Technology, Inc.2012-10-12
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM (K121651)Wrightmedicaltechnologyinc2012-10-12
GEMINUS FOSSA SPECIFIC PLATE SYSTEM (K122737)Skeletal Dynamics, LLC2012-10-03
AXSOS DISTAL LATERAL FEMUR TS LONG PLATES (K122308)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012-10-01
AFT PROXIMAL HUMERUS FRACTURE PLATE (K121672)Shoulder Options, Inc.2012-10-01
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM (K121425)Wrightmedicaltechnologyinc2012-10-01
SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT (K122623)Advanced Orthopaedic Solutions, Inc.2012-09-26
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM (K121302)Biomet Microfixation2012-09-19
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF (K113648)Aap Implantate AG2012-09-06
MAXLOCK EXTREME SYSTEM (K122005)Orthohelix Surgical Designs, Inc.2012-09-06
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T (K113652)Aap Implantate AG2012-08-30
GRIDLOCK PLATING SYSTEM (K121452)Trilliant Surgical, Ltd.2012-08-20
PIONEER STERNAL ASSIST IMPLANT SYSTEM (K120016)Pioneer Surgical Technology, Inc.2012-07-26
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE (K120903)Acumed, LLC2012-07-13
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE (K121601)Synthes USA2012-07-06
SYNTHES VA LCP ANKLE TRAUMA SYSTEM (K120854)Synthes USA2012-06-18
MINI MAXLOCK EXTREME PLATING SYSTEM (K121437)Orthohelix Surgical Designs, Inc.2012-06-13
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE (K120772)Zimmer GmbH2012-06-12
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM (K120689)Synthes (USA) Products, LLC2012-06-04
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS (K120360)Ortho Solutions Limited2012-05-29
EOS SMALL BONE FIXATION SYSTEM (K112794)TriMed, Inc.2012-05-10
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) (K120717)Synthes USA2012-05-08
ORTHOLOC 3DI HALLUX SYSTEM (K120359)Wrightmedicaltechnologyinc2012-05-03
MICROWARE BONE PLATES AND BONE SCREW (K111008)Microware Precision Co., Ltd.2012-05-02
APTUS PROXIMAL HUMERUS SYSTEM (K120108)Medartis AG2012-04-27
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK (K113760)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2012-04-25
OSTEOMED WRIST PLATING SYSTEM (K120015)Osteomed LP2012-04-24
OTIS-C PLUS (K120818)Science For Biomaterials2012-04-19
MINI MAXLOCK EXTREME PLATING SYSTEM (K120157)Orthohelix Surgical Designs, Inc.2012-04-10
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT (K120667)Smith & Nephew, Inc.2012-04-04
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS (K120802)Wrightmedicaltechnologyinc2012-04-02
LOCKING COMPRESSION PLATE SYSTEM (K112798)Shanghai Microport Orthopedics Co., Ltd.2012-03-29
SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX (K113733)Neoortho Produtos Ortopedicos S/A2012-03-23
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (K120070)Synthes USA2012-03-21
ADAPTIVE WEDGE (K110662)Adaptive Specialty, LLC2012-03-12
TRAUMA INTERNAL FIXATION SYSTEMS (K111663)DePuy Orthopaedics, Inc.2012-03-12
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL (K112663)Enhatch Orthopaedics, LLC2012-03-12
2.7MM LCP ULNA OSTEOTOMY SYSTEM (K113364)Synthes (USA) Products, LLC2012-02-29
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM (K120163)Acute Innovations, LLC2012-02-17
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678)Ortho Solutions Limited2012-02-07
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM (K113762)Arthrosurface, Inc.2012-02-06
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS (K113014)Wrightmedicaltechnologyinc2012-01-31
MAXLOCK EXTREME SYSTEM (K113048)Orthohelix Surgical Designs, Inc.2012-01-30
NCB STRAIGHT NARROW SHAFT PLATES (K113718)Zimmer GmbH2012-01-27
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM (K113318)Acute Innovations, LLC2012-01-12
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM (K113405)Suspension Orthopaedic Solutions, LLC2012-01-11
APTUS WRIST ARTHRODESIS PLATES (K112169)Medartis AG2012-01-06
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM (K112923)Suspension Orthopaedic Solutions, LLC2011-12-27
STRYKER RESORBABLE FIXATION SYSTEM (K113109)Stryker2011-12-23
AXSOS LOCKING PLATE SYSTEM (K112926)Stryker Corp.2011-12-19
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW (K112819)Xiamen Double Engline Medical Material Co., Ltd.2011-12-16
APTUS(R) DISTAL HUMERUS SYSTEM (K112560)Medartis AG2011-12-15
ORTHOLOC 3DSI LOCKING SCREWS (K113339)Wrightmedicaltechnologyinc2011-12-12
ASCENSION ATLAS HUMERAL PLATING SYSTEM (K110700)Ascension Orthopedics, Inc.2011-12-06
SYNTHES LCP PEDIATRIC PLATE SYSTEMS (K112085)Synthes (USA) Products, LLC2011-11-17
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES (K112406)Smith & Nephew, Inc.2011-11-14
TRIMED CLAVICLE FIXATION SYSTEM (K112509)TriMed, Inc.2011-11-04
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM (K112174)Zimmer, Inc.2011-10-26
SYNTHES STERNAL FIXATION SYSTEM (K112689)Synthes, Inc.2011-10-26
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA (K103513)Advanced Orthopaedic Solutions, Inc.2011-10-24
OSTEOMED HAND FUSION SYSTEM (K111419)Osteomed LP2011-10-07
EASYLOCK OSTEOSYSTEM (K111266)TriMed, Inc.2011-10-06
AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES (K112455)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2011-09-22
IFS PROFILE PLATES, SCREWS, AND WASHERS (K110086)Internal Fixation Systems, Inc.2011-09-09
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS (K111620)Skeletal Dynamics, LLC2011-08-23
TRIMED RADIOCARPAL FUSION SYSTEM (K102785)TriMed, Inc.2011-08-19
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS (K111432)Wrightmedicaltechnologyinc2011-08-19
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540)Synthes (Usa)2011-08-08
ORTHOPEDIATRICS BLADE PLATE SYSTEM (K110959)OrthoPediatrics Corp.2011-08-05
ARTHREX DISTAL EXTREMITY PLATE SYSTEM (K111253)Arthrex, Inc.2011-08-02
MAESTRO WRIST PLATING SYSTEM (K110271)Biomet Manufacturing Corp2011-07-22
EXPLOR RADIAL HEAD PLATING SYSTEM (K110201)Biomet, Inc.2011-07-21
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM (K110320)Biomet Manufacturing Corp2011-07-21
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES (K110670)Smith & Nephew, Inc.2011-07-12
OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM (K111326)Graham Medical Technologies, LLC2011-07-06
APTUS FOOT 3.5 SYSTEM (K110908)Medartis AG2011-06-28
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM (K111086)OrthoPediatrics Corp.2011-06-17
MINI VARIABLE SYSTEM (K111041)Orthohelix Surgical Designs, Inc.2011-06-06
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM (K111039)Zimmer, Inc.2011-05-19
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM (K110574)Biomet Microfixation, Inc.2011-05-18
MAHE FIXATION PLATE AND SCREW SYSTEM (K102845)Mahe Medical GmbH2011-05-13
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM (K110125)Synthes USA2011-04-21
NEWDEAL COMPRESSION PLATES (K093914)Newdeal Sas2011-04-14
AXSOS (TM) LOCKING PLATE SYSTEM (K110476)Stryker Corp.2011-03-18
MEMOMETAL NAVIS BONE PLATING SYSTEM (K101930)Memometal Technologies2011-03-15
PICCOLO COMPOSITE PLATE SYSTEM (K102597)N.M.B. Medical Applications, Ltd.2011-02-24
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS (K110176)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2011-02-15
APTUS ULNA PLATES (K103332)Medartis AG2011-01-24
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (K103243)Synthes (Usa)2011-01-21
CONGRUENT BONE PLATE SYSTEM (K102998)Acumed, LLC2011-01-04
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