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Orthopedic

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

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RecordFirmDate
S-BONE HIP TOOL (K052538)Orthopedic Sciences, Inc.2005-10-07
ARCTEC SEMIRIGID PLATING SYSTEM (K051044)Altiva Corp.2005-10-07
LANX VBR SYSTEM (K052384)Lanx, LLC2005-10-07
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR (K052491)Axya Medical, Inc.2005-10-07
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID (K052472)DePuy Orthopaedics, Inc.2005-10-06
POROUS COATED ACETABULAR COMPONENTS (K050124)Biomet, Inc.2005-10-04
LINEAGE HA ACETABULAR SHELLS (K043099)Wrightmedicaltechnologyinc2005-09-29
MERRIES UNI-OSTEO, MODEL CS30250-CS10102 (K051698)Merries International, Inc.2005-09-29
COPELAND EAS HUMERAL RESURFACING HEADS (K051843)Biomet, Inc.2005-09-29
RINGLOC BI-POLAR ACETABULAR COMPONENT (K051569)Biomet, Inc.2005-09-29
LOW PROFILE PLATE AND SCREW SYSTEM (K052614)Arthrex, Inc.2005-09-28
CERAMENT BONE VOID FILLER (K051951)Bonesupport AB2005-09-28
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS (K052131)Depuy Spine, Inc.2005-09-28
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 (K052309)Saehan Corp.2005-09-27
ACCOLADE RPS HIP STEM (K052542)Stryker Orthopaedics2005-09-27
E-POLY (VITAMIN E) ACETABULAR LINERS (K050327)Biomet, Inc.2005-09-27
ARTHREX TENODESIS FAMILY (K051726)Arthrex, Inc.2005-09-27
ACCOLADE HFX FEMORAL STEM (K051741)Stryker Orthopaedics2005-09-26
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS (K050637)Ortho Development Corp.2005-09-23
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM (K052376)Medtronic Sofamor Danek2005-09-23
SYNTHES PANGEA SYSTEM (K052123)Synthes (Usa)2005-09-23
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (K051978)Implex Corp.2005-09-23
VERTEX RECONSTRUCTION SYSTEM (K052402)Medtronic Sofamor Danek2005-09-23
MODIFICATION TO: STRYKER SPINE OASYS SYSTEM (K052317)Stryker Spine2005-09-21
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM (K051697)Medical Device Advisory Development Group2005-09-21
REPROCESSED EXTERNAL FIXATION DEVICE (K051957)Sterilemed, Inc.2005-09-21
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM (K051678)Synthes (Usa)2005-09-21
EBI DYNAFIX VISION FOOTPLATE SYSTEM (K052239)Ebi, L.P.2005-09-21
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX (K052247)Abbott Spine, Inc.2005-09-14
OSTEOPAL V (K050085)Heraeus Kulzer,GmbH2005-09-14
DORSAL NAIL PLATE, ANATOMICAL (K052248)Hand Innovations, LLC2005-09-14
B-BOP PLATE (K052152)New Deal, S.A.2005-09-13
SYNTHES VECTRA-T SYSTEM (K051665)Synthes Spine2005-09-09
MODIFICATION TO XIA SPINAL SYSTEM (K052181)Stryker Spine2005-09-08
VOLAR PLATE SYSTEM (K052150)Dvo Extremity Solutions, LLC2005-09-08
LEGEND ALL-POLY CUP (K051407)Ortho Development Corp.2005-09-08
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES (K051986)Synthes (Usa)2005-09-08
CONNEXUS, .5CC, MODEL 023000-005 (K052098)Isotis Orthobiologics, Inc.2005-09-07
VERTEBRON PSS PEDICLE SCREW SYSTEM (K051716)Vertebron, Inc.2005-09-07
REFIX INTERNAL FRACTURE FIXATION SCREWS (K050388)Xtremi-T, LLC2005-09-07
PARALLAX EZFLOW CEMENT DELIVERY SYSTEM (K051820)Arthrocare Corp.2005-09-06
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE (K051556)Exactech, Inc.2005-09-06
SBI WRISTFIT (K051747)Small Bone Innovations, LLC2005-09-06
POROUS COATED DISCOVERY ELBOW (K051975)Biomet, Inc.2005-09-06
MBARESORB IMPLANT (K051611)Kinetikos Medical, Inc.2005-09-06
MIOT PLATING SYSTEM (K051945)Orthofix Srl2005-09-06
TAPERED COMPRESSION PIN (K051740)Nexa Orthopedics, Inc.2005-09-06
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K051616)Vanguard Medical Concepts, Inc.2005-09-06
SC CERAMIC BALL HEADS (K052237)Orthopedic Alliance, LLC2005-09-06
OSTEOMIMETIC SYNTHETIC BONE MATRIX (K051775)Biomimetic Pharmaceuticals, Inc.2005-09-06
R&R EXTERNAL FIXATION SYSTEM (K052005)R&R Medical, Inc.2005-09-06
TRIABSORB COMPOSITE SCREW (K050468)Advanced Biomaterials2005-08-31
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER (K052086)Encore Medical, Inc.2005-08-31
TSRH SPINAL SYSTEM (K052144)Medtronic Sofamor Danek2005-08-31
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM (K051380)Howmedica Osteonics Corp.2005-08-30
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES (K052072)Abbott Spine, Inc.2005-08-29
U1 HIP SYSTEM - BIPOLAR (K050269)United Orthopedic Corp.2005-08-29
SIJF CANNULATED SCREW SYSTEM (K051296)Depuy Spine, Inc.2005-08-26
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K052062)Alliance Medical Corp.2005-08-25
MATRYX INTERFERENCE SCREW (K052080)Linvatec Biomaterials, Inc.2005-08-25
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K052064)Alliance Medical Corp.2005-08-25
UNIGLIDE UNICONDYLAR KNEE PROSTHESIS (K050764)Corin USA2005-08-24
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567)Medartis, Inc.2005-08-23
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K052180)Medtronic Sofamor Danek2005-08-23
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K052065)Alliance Medical Corp.2005-08-22
MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K052187)Medtronic Sofamor Danek2005-08-22
MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL (K052058)Fournitures Hospitalieres Industrie2005-08-22
PROFEMUR RENAISSANCE HIP STEM (K051995)Wrightmedicaltechnologyinc2005-08-22
FR.O.H. CALCANEUS REPAIR SYSTEM (K051642)I.T.S. Implantat-Technologie-Systeme GmbH2005-08-22
CONSERVE TOTAL FEMORAL HEAD (K051348)Wrightmedicaltechnologyinc2005-08-19
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM (K051973)Stryker Spine2005-08-18
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES (K052069)Globus Medical, Inc.2005-08-17
NUBIC SPINAL IMPLANT (K052096)Signus Medical, LLC2005-08-16
TSRH SPINAL SYSTEM (K052054)Medtronic Sofamor Danek2005-08-16
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS (K050222)Biomet, Inc.2005-08-16
STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES (K051615)Regeneration Technologies, Inc.2005-08-15
U2 ACETABULAR COMPONENT (K050262)United Orthopedic Corp.2005-08-15
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE (K051827)Joimax GmbH2005-08-12
PILONPLATE WITH ANGULAR STABILITY (K052011)I.T.S. Implantat-Technologie-Systeme GmbH2005-08-10
CHARLOTTE COMPRESSION PLATE (K051908)Wrightmedicaltechnologyinc2005-08-10
SBI K-WIRES (K051605)Small Bone Innovations, LLC2005-08-10
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS (K051479)Biomet Manufacturing, Inc.2005-08-10
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (K050655)Kapp Surgical Instrument, Inc.2005-08-08
MONDEAL CONTOUR HO SYSTEM (K050657)Kapp Surgical Instrument, Inc.2005-08-08
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM (K040627)DePuy Orthopaedics, Inc.2005-08-05
AVL HINGE KNEE SYSTEM (K051570)Biomet, Inc.2005-08-05
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K052037)Howmedica Osteonics Corp.2005-08-05
CHARLOTTE SMALL MTP FUSION PLATE (K051884)Wrightmedicaltechnologyinc2005-08-05
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (K043547)Biomet, Inc.2005-08-05
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE (K051989)Depuy Mitek, A Johnson & Johnson Company2005-08-05
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K051983)Axya Medical, Inc.2005-08-05
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE (K051385)Biomet, Inc.2005-08-05
OPTIMA SPINAL SYSTEM (K051971)U&I Corp.2005-08-04
COBALT BONE CEMENT (K051496)Biomet, Inc.2005-08-04
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 (K051362)Inion OY2005-08-04
COBALT G HV BONE CEMENT (K051532)Biomet, Inc.2005-08-03
OSTEOCURE RESORBABLE BEAD KIT (K051406)Nexa Orthopedics, Inc.2005-08-01
T2 ANKLE ARTHRODESIS NAIL (K051590)Howmedica Osteonics Corp.2005-07-29
AFT (K042125)Musculoskeletal Transplant Foundation2005-07-28
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM (K051600)Synthes (Usa)2005-07-27
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