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Orthopedic

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

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RecordFirmDate
MODIFICATION TO TSRH SPINAL SYSTEM (K011067)Medtronic Sofamor Danek, Inc.2001-05-04
APEX FIXATION PINS (K011136)Howmedica Osteonics Corp.2001-05-04
ADJUSTABLE LARGE FIXATOR SYSTEM (K010344)Synthes (Usa)2001-05-03
MODULAR FOOT SYSTEM - 2.7 MM MODULE (K010321)Synthes (Usa)2001-05-02
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) (K010322)Orthodyne, Inc.2001-05-02
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION (K003740)Aesculap, Inc.2001-04-27
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA (K010529)Medtronic Sofamor Danek USA, Inc.2001-04-27
SMARTSCREW MODEL 222006...227510 (K003077)Bionx Implants, Ltd.2001-04-26
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS (K011081)Exactech, Inc.2001-04-24
SYNTHES SYNMESH SPACER SYSTEM (K003275)Synthes (Usa)2001-04-23
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS (K010810)DePuy Orthopaedics, Inc.2001-04-18
CLS VARUS STEM/CLS 135 STEM (K010839)Sulzer Orthopedics, Inc.2001-04-18
MODIFICATION TO OSTEONICS SPINAL SYSTEM (K010845)Howmedica Osteonics Corp.2001-04-18
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT (K010170)Howmedica Osteonics Corp.2001-04-18
WUJIN #3 FEMORAL NAIL (K010149)Biopro, Inc.2001-04-17
REFLEX ANTERIOR CERVICAL PLATE SYSTEM (K010115)Howmedica Osteonics Corp.2001-04-16
AVL HINGE KNEE SYSTEM (K010774)Biomet, Inc.2001-04-13
MOSS MIAMI 5.5MM TITANIUM PIN NUT (K010742)Depuyacromed2001-04-12
TSRH SPINAL SYSTEM (K010720)Medtronic Sofamor Danek, Inc.2001-04-11
LFIT V40 FEMORAL HEAD COMPONENTS (K010757)Howmedica Osteonics Corp.2001-04-11
ULNAR HEAD IMPLANT (K010786)Avanta Orthopaedics, Inc.2001-04-11
SOCON SPINAL SYSTEM (K003463)Aesculap, Inc.2001-04-11
MODIFICATION TO SYNTHES (USA) POLYPIN (K003527)Synthes (Usa)2001-04-09
LPC-PLUS ACETABULAR CUP (K003274)Plus Orthopedics2001-04-06
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS (K010776)Corin USA2001-04-06
AVON PATELLO-FEMORAL JOINT PROSTHESIS (K010100)Howmedica Osteonics Corp.2001-04-06
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS (K010124)Arthrex, Inc.2001-04-06
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER (K010171)DePuy Orthopaedics, Inc.2001-04-06
T2 FEMORAL NAIL (K010801)Howmedica Osteonics Corp.2001-04-06
COPELAND RESURFACING HUMERAL HEADS (K010664)Biomet Manufacturing, Inc.2001-04-05
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) (K010685)Zimmer, Inc.2001-04-02
DJ ORTHOPEDICS FEMORAL ANCHOR (K002829)Dj Orthopedics, LLC2001-03-26
MODIFICATION TO SYNERGY SPINAL SYSTEM (K010515)Interpore Cross Intl.2001-03-22
DJ ORTHOPEDICS TIBIAL ANCHOR (K003960)Dj Orthopedics, LLC2001-03-21
PECTOFIX STERNAL REPAIR WIRE (K003951)Pectofix, Inc.2001-03-21
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR (K003971)Axya Medical, Inc.2001-03-21
APEX MODULAR ZIRCONIA FEMORAL HEAD (K003923)Apex Surgical, LLC2001-03-20
PORTRAIT FEMORAL COMPONENT (K010560)Biomet, Inc.2001-03-20
LACTOSORB 5.0 MM WASHER (K001581)Biomet, Inc.2001-03-20
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION (K001535)Ortho Tec, LLC2001-03-20
MODIFICATION TO TRIDENT ALL POLY CUP (K010310)Howmedica Osteonics Corp.2001-03-20
BAUMER CEMENTED HIP PROSTHESIS (K003975)Baumer, S.A2001-03-19
TRIFIX SPINAL FIXATION SYSTEM (K010535)Endius, Inc.2001-03-19
SUPER REVO SUTURE ANCHOR (K003984)Linvatec Corp.2001-03-19
BAUMER MULLER HIP PROSTHESIS (K003976)Baumer, S.A2001-03-19
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS (K003910)Zimmer, Inc.2001-03-19
OPTETRAK B-SERIES TOTAL KNEE SYSTEM (K010434)Exactech, Inc.2001-03-13
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM (K010437)Ebi, L.P.2001-03-13
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) (K003911)Terray Corp.2001-03-13
MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM (K001354)Biomedical Ent., Inc.2001-03-13
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM (K010367)DePuy Orthopaedics, Inc.2001-03-09
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM (K003816)Arthrex, Inc.2001-03-09
ALLOFIT ACETABULAR SYSTEM (K003758)Sulzer Orthopedics, Inc.2001-03-07
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW (K002274)Smith & Nephew, Inc.2001-03-07
SHAVER ABLATOR (K002088)Linvatec Corp.2001-03-06
TI-REPLICA HIP STEM (K003875)DePuy Orthopaedics, Inc.2001-03-01
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X (K003893)Oratec Interventions, Inc.2001-03-01
ANATOMICAL PRESS-FIT HUMERAL STEM (K003801)Sulzer Orthopedics, Inc.2001-02-28
TRITON HIP SYSTEM (K003649)Hayes Medical, Inc.2001-02-23
FREEDLAND TENSION SYSTEM (K003648)Etzem Technologies, Inc.2001-02-23
CD HORIZON SPINAL SYSTEM (K010249)Medtronic Sofamor Danek, Inc.2001-02-23
MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 (K003629)Terray Corp.2001-02-22
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 (K003659)Bionx Implants, Inc.2001-02-20
SYNTHES HAMSTRING LOOP (K003700)Synthes (Usa)2001-02-20
PERFECTA AND EXTEND (K004032)Wrightmedicaltechnologyinc2001-02-15
ENHANCED POLYETHYLENE KNEE PROSTHESES (K001147)Howmedica Osteonics Corp.2001-02-15
TRI-FIT FEMORAL STEM (K010243)Corin USA2001-02-15
MITEK 2GII MENISCAL REPAIR SYSTEM (K002406)Mitek Products2001-02-15
SMITH & NEPHEW SUTURE ANCHOR (K003599)Smith & Nephew, Inc.2001-02-15
DYONICS CONTROL RF SYSTEM (K003572)Smith & Nephew, Inc.2001-02-15
OFFSET TIBIAL TRAY (K010212)Biomet, Inc.2001-02-14
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS (K003566)Smith & Nephew, Inc.2001-02-14
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES (K003695)Micro-Medical Devices, Inc.2001-02-14
KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A (K010246)Kyphon, Inc.2001-02-14
STERILE BUTTON PLATE (K010121)Synthes (Usa)2001-02-09
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM (K003743)Synthes (Usa)2001-02-09
AML HIP PROSTHESIS (K003800)DePuy Orthopaedics, Inc.2001-02-09
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S (K010120)Exactech, Inc.2001-02-09
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM (K010179)Ebi, L.P.2001-02-09
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM (K010282)Stelkast Company2001-02-09
CEMEX SYSTEM GUN APPLICATION VERSION (K000943)Exactech, Inc.2001-02-08
TAPER-FIT TOTAL HIP SYSTEM (K003666)Corin USA2001-02-08
CANNULATED SCREW SYSTEM (K003496)Pioneer Surgical Technology2001-02-08
BIOLOK SCREW, BIOSTEON SCREW (K003641)Biocomposites, Ltd.2001-02-08
PROTRACT PRESS FIT HIP STEM-HA COATED (K010241)Stelkast Company2001-02-08
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS (K010081)Exactech, Inc.2001-02-05
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 (K003478)Zimmer, Inc.2001-02-05
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM (K010003)Ebi, L.P.2001-01-31
COLLES C SERIES FRAME STERILE PACK (K003397)DePuy Orthopaedics, Inc.2001-01-29
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII (K002652)Stryker Corp.2001-01-26
FMP METAL/METAL ACETABULAR INSERT (K003250)Encore Orthopedics, Inc.2001-01-25
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY (K004013)Implex Corp.2001-01-25
PARSFIX CABLE-SCREW SYSTEM (K003351)Spinal Concepts, Inc.2001-01-24
OTI CERAMIC FEMORAL HEAD SYSTEM (K003316)Osteoimplant Technology, Inc.2001-01-19
BIOMET'S MINIMALLY CONSTRAINED ELBOW (K003253)Biomet, Inc.2001-01-12
MAXIM KNEE SYSTEM (K010027)Biomet, Inc.2001-01-12
CONTOUR LABRAL NAIL, MODEL 533520A (K003970)Bionx Implants, Inc.2001-01-12
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST (K003848)Howmedica Osteonics Corp.2001-01-11
LACTOSORB SCREW ANCHOR (K003273)Biomet, Inc.2001-01-11
TRIAD II MODULAR TOTAL HIP SYSTEM (K003199)Osteoimplant Technology, Inc.2001-01-10
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