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Orthopedic

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

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RecordFirmDate
VERSAFIT CUP DOUBLE MOBILITY SYSTEM (K083116)Medacta International S.A.2009-04-07
FREEDOM METAL BACKED TIBIAL COMPONENT (K090411)Maxx Orthopedics, Inc.2009-04-07
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM (K090316)Lanx, Inc.2009-04-07
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (K082679)Sintea Biotech, Inc.2009-04-07
RIGIDFIX BIOCRYL CROSS PIN KITS (K090669)Depuy Mitek, A Johnson & Johnson Company2009-04-03
REGENEREX PATELLA COMPONENTS (K083782)Biomet Manufacturing Corp2009-04-03
MAK OSS KNEE FEMORAL COMPONENTS (K083779)Biomet Manufacturing Corp2009-04-03
BLACK WIDOW ANTERIOR BUTTRESS PLATE (K081770)Omni Surgical, L.P.2009-04-02
INTERGRO DBM (K082793)Biomet Spine2009-04-02
SPINESMITH CYNCH SPINAL SYSTEM (K090376)Spine Smith Partners L.P.2009-04-01
XIA 3 SPINAL SYSTEM (K083393)Stryker Spine2009-04-01
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM (K090047)Synthes (Usa)2009-04-01
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS (K090492)DePuy Orthopaedics, Inc.2009-03-31
THEKEN ATOLL OCT SPINAL SYSTEM (K083863)Theken Spine, LLC2009-03-27
ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) (K083161)Conmed Linvatec2009-03-27
RELIANCE SPINAL SCREW SYSTEM (K081978)Reliance Medical Systems, LLC2009-03-26
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM (K083020)Stryker Corp.2009-03-26
AOS PROXIMAL HUMERAL NAIL (K090478)Advanced Orthopaedic Solutions, Inc.2009-03-26
COALITION SPACER (K083389)Globus Medical, Inc.2009-03-26
DISCOVERY ELBOW - X-SMALL (K090473)Biomet Manufacturing Corp2009-03-25
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM (K083562)Stryker Corp.2009-03-25
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 (K083792)Medshape Solutions2009-03-25
EQUIVABONE (K090310)Etex Corp.2009-03-24
ACE FISCHER EXTERNAL FIXATION SYSTEM (K083789)DePuy Orthopaedics, Inc.2009-03-23
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM (K083843)DePuy Orthopaedics, Inc.2009-03-20
OSCAR BONE RESECTOR (K083830)Orthosonics, Ltd.2009-03-20
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE (K083425)Adaptive Specialty, LLC2009-03-20
NUVASIVE HELIX-T ACP SYSTEM (K083341)Nuvasive, Inc.2009-03-20
MODIFICATION TO: DSS STABILIZATION SYSTEM (K090408)Paradigm Spine, LLC2009-03-20
EOI SPINAL SYSTEM (K083825)Expanding Orthopedics, Inc.2009-03-19
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 (K083490)Biopro, Inc.2009-03-18
SALTO TALARIS TOTAL ANKLE PROSTHESIS (K090076)Tornier2009-03-17
MAGNUM M FIXATION DEVICE (K090380)Arthrocare Corp.2009-03-13
REVELATION STEM, MODEL 427-21/42-080/180 (K083651)Encore Medical L.P.2009-03-13
THEKEN ATOLL CERVICO-THORACIC SYSTEM (K083073)Theken Spine, LLC2009-03-13
UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM (K081813)U.S. Implant Solutions, LLC2009-03-12
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 (K090124)Depuy Mitek, A Johnson & Johnson Company2009-03-11
PEDINAIL INTRAMEDULLARY NAILING SYSTEM (K083726)OrthoPediatrics Corp.2009-03-11
BIOLOX DELTA CERAMIC FEMORAL HEADS (K083762)Smith & Nephew, Inc.2009-03-11
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S (K090374)DePuy Orthopaedics, Inc.2009-03-11
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES (K083694)Synthes (Usa)2009-03-06
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER (K082924)Wrightmedicaltechnologyinc2009-03-06
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 (K083619)Parcus Medical, LLC2009-03-06
KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE (K083609)Kfx Medical2009-03-06
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K083642)DePuy Orthopaedics, Inc.2009-03-06
EXPEDIUM SPINE SYSTEM (K090230)Depuy Spine, Inc.2009-03-06
PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 (K090075)Parcus Medical, LLC2009-03-06
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C (K083558)Medacta International S.A.2009-03-06
APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM (K083612)Cayenne Medical, Inc.2009-03-04
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES (K083573)Synthes (Usa)2009-03-04
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM (K083311)Aesculap Implant Systems, Inc.2009-03-04
MESA SPINAL SYSTEM (K080611)K2m, Inc.2009-03-04
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM (K090252)Lanx, Inc.2009-03-04
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM (K083607)Cayenne Medical, Inc.2009-03-04
R3 CONSTRAINED LINER, CONSTRAINED LINER (K083566)Smith & Nephew, Inc.2009-03-03
REPROCESSED EXTERNAL FIXATION DEVICE (K083636)Sterilmed, Inc.2009-03-02
AVS TL PEEK SPACERS (K083661)Stryker Corp.2009-02-27
TIGER DISCECTOMY DEVICE (K081240)Spinal Devices, LLC2009-02-27
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) (K083654)Zimmer, Inc.2009-02-26
GRAFTYS HBS (K082498)Graftys2009-02-25
PACP (K083663)Pioneer Surgical Technology2009-02-25
SOLAS ANATOMIX SPINAL SYSTEM (K083178)Biotechni America Spine Group, Inc.2009-02-23
GAMMA-BSM, BETA-BSM (K090242)Etex Corp.2009-02-20
TRANSITION STABILIZATION SYSTEM (K073439)Globus Medical, Inc.2009-02-20
ADVANCE A-CLASS TIBIAL INSERT (K081479)Wrightmedicaltechnologyinc2009-02-20
INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (K090177)Inion OY2009-02-20
FANNING-PAPPAS MODULAR KNEE BEARING (K081400)Endotec, Inc.2009-02-20
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS (K083497)Zimmer, Inc.2009-02-19
ANATOMIC LOCKING PLATING SYSTEM (K082300)DePuy Orthopaedics, Inc.2009-02-18
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) (K082468)Omni Life Science, Inc.2009-02-18
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 (K083469)Metasurg2009-02-13
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES (K083827)Biomet Manufacturing Corp2009-02-13
LUCENT MAGNUM (K083475)Spinal Elements, Inc.2009-02-13
LDR SPINE ROI-C IMPLANT (K083857)Ldr Spine USA2009-02-12
TORNIER, INC., INSITE SUTURE ANCHORS (K083268)Tornier, Inc.2009-02-12
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (K090103)Biomet, Inc.2009-02-11
MODIFICATION TO DEPUY NEUFLEX PIP FINGER (K083107)DePuy Orthopaedics, Inc.2009-02-09
INTRAMEDULLARY FIXATION ROD (IFS) (K083458)Novalign Orthopaedics, Inc.2009-02-09
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM (K082371)Smith & Nephew, Inc.2009-02-09
MASTERGRAFT RESORBABLE CERAMIC GRANULES (K082918)Medtronic Sofamor Danek2009-02-09
MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 (K083447)Memometal Technologies2009-02-06
FREEDOM TOTAL KNEE SYSTEM (K082019)Maxx Orthopedics, Inc.2009-02-06
DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE (K081888)Spineart2009-02-06
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM (K083439)Synthes (Usa)2009-02-05
BIODRIVE CANNULATED SCREW SYSTEM (K082874)Biomet Trauma2009-02-05
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER (K082833)Nutek Orthopaedics, Inc.2009-02-05
LDR SPINE ROI INTERBODY FUSION SYSTEM (K082262)Ldr Spine USA2009-02-02
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (K083338)Seaspine, Inc.2009-02-02
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM (K090091)Mylad Orthopedic Solutions, LLC2009-02-01
SMITH & NEPHEW PEEK INTERFERENCE SCREW (K083226)Smith & Nephew Endoscopy, Inc.2009-01-30
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW (K083635)Smith & Nephew Endoscopy, Inc.2009-01-30
NOVEL SPINAL SYSTEM (K081153)Medyssey Co, Ltd.2009-01-30
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM (K083286)OrthoPediatrics Corp.2009-01-30
ANTERIOR BUTTRESS PLATE (K081548)Scient'X USA, Inc.2009-01-29
PILOT SPINAL SYSTEM (K083865)Life Spine2009-01-28
CALTRIX RESORBABLE BONE VOID FILLER (K083279)Ag Digital Technology Corp.2009-01-28
AEQUALIS HUMERAL NAIL SYSTEM (K082754)Tornier2009-01-27
APOLLO ANTERIOR CERVICAL PLATE SYSTEM (K082504)Apollo Spine, Inc.2009-01-27
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW (K082810)Arthrex, Inc.2009-01-23
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM (K083826)Allez Spine, LLC2009-01-22
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