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Orthopedic

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

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RecordFirmDate
AEQUALIS FX2 (K141345)Tornier S.A.S.2014-11-18
Amedica Valeo II Interbody Fusion Device (K142347)Amedica Corp.2014-11-18
ZIP MIS INTERSPINOUS FUSION SYSTEM (K141317)Aurora Spine, Inc.2014-11-17
SAIPH KNEE SYSTEM (K140222)Matortho2014-11-17
A-LINK Z (K133827)Osteo Vasive, LLC2014-11-17
Speed, Speed Shift, Speed Titan, Speed Arc (K142292)Biomedical Enterprises, Inc.2014-11-17
Restoration Anatomic Shell (K142462)Stryker Orthopaedics2014-11-14
JOURNEY II XR KNEE SYSTEM (K141471)Smith & Nephew, Inc.2014-11-14
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM (K142161)Conformis, Inc.2014-11-14
TITAN Modular Total Shoulder System (K142413)Ascension Orthopedics2014-11-14
Biomet Headless Compression and Twist-off Screws (K142658)Biomet Manufacturing Corp2014-11-13
AERO-LL LUMBAR CAGE SYSTEM (K142066)Stryker Corporation2014-11-13
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM (K141571)Orthofix Srl2014-11-12
Zimmer Plates and Screws (ZPS), Forte Screws (K142836)Zimmer, Inc.2014-11-12
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K140961)Stryker Trauma AG2014-11-10
EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments (K142550)Microport Orthopedics, Inc.2014-11-07
ENCORE HUMERAL SHOULDER STEM (K141990)Encore Medical L.P.2014-11-07
MIDLINE II TI (K141942)Centinel Spine, Inc.2014-11-07
SMR 40MM GLENOSPHERE (K142139)Lima Corporate S.P.A.2014-11-07
INS HILDEN TIBIAL ARZZT (K133166)Truemed Group, LLC2014-11-06
NAKOMA ACP (K141993)Alliance Partners, LLC2014-11-06
LINK MP RECONSTRUCTION PROSTHESIS (K142187)Waldemar Link GmbH & Co. KG2014-11-06
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED (K140130)Encore Medical L.P.2014-11-06
CAPRI (K142016)K2m, Inc.2014-11-06
MAXAN ANTERIOR CERVICAL PLATE SYSTEM (K133518)Biomet Spine (Aka Ebi, LLC)2014-11-05
PASS LP SPINAL SYSTEM (K140738)Medicrea International2014-11-04
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM (K141676)Renovis Surgical Technologies, Inc.2014-11-04
NOVABONE BIOACTIVE STRIP (K141207)Novabone Products, LLC2014-10-31
Sternal Closure System (K142484)Jace Medical, LLC2014-10-31
AIS MODULIFT VBR SYSTEM (K142150)Aesculap Implant System, Inc.2014-10-29
REBOSSIS (K142090)Orthorebirth Co., Ltd.2014-10-29
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM (K142050)Nu Vasive, Incorporated2014-10-29
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON (K141912)Advanced Orthopaedic Solutions, Inc.2014-10-29
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (K142053)Zimmer Spine, Inc.2014-10-29
Xia® Growth Rod Conversion Set (K142114)Stryker Corporation2014-10-27
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL (K141407)Biomet, Inc.2014-10-27
FLOSPINE PEDICLE SCREW SYSTEM (K141850)Flospine2014-10-27
CD HORIZON Spinal System (K142847)Medtronic Sofamor Danck USA, Inc.2014-10-27
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL (K141953)Titan Spine, LLC2014-10-27
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) (K141331)Biomet, Inc.2014-10-27
CrossCLIP Implant System (K142727)Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems2014-10-24
STALIF CTI, STALIF C (K142079)Centinel Spine, Inc.2014-10-24
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM (K141714)Wrightmedicaltechnologyinc2014-10-24
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, (K142574)Depuy Mitek, A Johnson & Johnson Company2014-10-24
ABACUS (TM) SPACER SYSTEM (K142101)Spine Wave, Inc.2014-10-23
VALOR Hindfoot Fusion Nail System (K142602)Wrightmedicaltechnologyinc2014-10-22
Zimmer Periarticular Plating System (K142579)Zimmer, Inc.2014-10-22
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM (K142281)Zimmer, Inc.2014-10-22
CD HORIZON SPINAL SYSTEM (K141604)Medtronic Sofamor Danek USA, Inc.2014-10-21
Xia 3 Spinal System (K142381)Stryker Corp.2014-10-21
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K142026)Spinefrontier, Inc.2014-10-20
AILERON INTERSPINOUS FIXATION SYSTEM (K140236)Life Spine, Inc.2014-10-20
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT (K141600)Pioneer Surgical Technology, Inc. (Rti Surgical, I2014-10-17
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL (K142589)Titan Spine, LLC2014-10-17
G-Lok and G-Lok XL Extender (K142653)T.A.G. Medical Products Corporation, Ltd.2014-10-16
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K142095)Renovis Surgical Technologies, Inc.2014-10-15
COGENT MED-LIF XL (K142193)Cogent Spine, LLC2014-10-15
JULIET PO (K142277)Spineart2014-10-14
INTEGRA EXTERNAL FIXATION SYSTEM (K140463)Ascension Orthopedic2014-10-10
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM (K141106)Folsom Metal Products, Inc. Dba Frontier Devices2014-10-10
COROENT TI-C SYSTEM (K140319)Nuvasive, Inc.2014-10-09
BIOMET FUSION SYSTEM (K141791)Biomet Spine2014-10-09
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY (K141972)Total Joint Orthopedics, Inc.2014-10-09
GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM (K133245)Genesys Spine2014-10-08
NEEDLE VIEW CH SCOPE KITS (K141326)Biovision Technologies, LLC2014-10-08
RESIDUAL LIMB LENGTHENING SYSTEM (K141739)Ellipse Technologies, Inc.2014-10-07
HyProCure II (K142534)Graham Medical Technologies, LLC Dba Gramedica2014-10-03
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM (K142442)Zimmer, Inc.2014-10-03
EMERGE MEDICAL IM NAIL SYSTEM (K141347)Emerge Medical2014-10-02
DIVERGENCE Anterior Cervical Fusion System (K142450)Medtronic Sofamor Danek USA, Inc.2014-10-01
EXPEDIUM Spine System/Synapse System (K142460)Johnson and Johnson2014-10-01
INNESIS PEEK TL CAGE (K140577)Bk Meditech, Co., Ltd.2014-10-01
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION (K141314)Spineart2014-09-29
HELICAL RIDGE PEEK INTERFERENCE SCREW (K141290)MedShape, Inc.2014-09-29
CLYDESDALE(R) SPINAL SYSTEM (K133577)Medtronic Sofamor Danek USA, Inc.2014-09-26
I.T.S. Hand Locking Plates System - HLS (K142418)I.T.S. GmbH2014-09-26
PRO-LINK WEDGE SYSTEM (K141905)Life Spine2014-09-26
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (K141897)Synthes USA Products, LLC2014-09-25
POLARIS SPINAL SYSTEM - HA COATED (K141804)Biomet Spine, LLC2014-09-25
4WEB SPINAL IMPLANT PRODUCTS (K142112)4Web, Inc.2014-09-23
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL (K141103)Neoortho Produtos Ortopedicos S/A2014-09-23
OPTIO-C ANTERIOR CERVICAL SYSTEM (K141500)Zimmer Spine, Inc.2014-09-23
LONGBOW SPACER SYSTEM (K133717)Life Spine2014-09-19
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM (K141697)Zimmer, Inc.2014-09-18
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM (K140613)Ellipse Technologies, Inc.2014-09-18
MOBIS II ST SPINAL IMPLANT (K141405)Signus Medizintechnik GmbH2014-09-16
Sirius Femoral Stem, Size 30A (K142295)Biomet, Inc.2014-09-15
Flower Upper Extremity Plating Set (K142306)Flower Orthopedics Corporation2014-09-15
ZVPLASTY (K141419)Zavation, LLC2014-09-12
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES (K142134)Conmed Corporation, Largo2014-09-12
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM (K141949)Aap Implantate AG2014-09-12
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS (K141235)Microport Orthopedics, Inc.2014-09-12
TRIDENT FUSION IMPLANT (K141937)Vilex IN Tennessee, Inc.2014-09-10
Apollo Suture Anchor System and Titan Screws (K142230)Valeris Medical2014-09-10
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS (K140390)Biomet Manufacturing Corp2014-09-10
VIA SPINOUS PROCESS FIXATION SYSTEM (K142213)Spineology, Inc.2014-09-10
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS (K141835)Spineart2014-09-10
ARENA-C (K141337)Spinefrontier, Inc.2014-09-08
RANGE/MESA/DENALI SPINAL SYSTEM (K141873)K2m, Inc.2014-09-08
MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP (K141824)Medtronic Sofamor Danek, Inc.2014-09-05
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