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Orthopedic

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

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RecordFirmDate
OLYMPIC Posterior Spinal Fixation System (K153446)Astura Medical2016-04-08
ICONACY(TM) I-Hip(TM) (K160266)Iconacy Orthopedic Implants, LLC2016-04-08
U2 Bipolar Implant and 22mm Femoral Head (K152439)United Orthopedic Corporation2016-04-07
KLS Martin LSS Plating System (K151983)KLS Martin L.P.2016-04-06
SMR 3-Pegs Glenoids (K153722)Lima Corporate S.P.A.2016-04-06
KLS Martin Thoracic Plating System (K153482)KLS-Martin L.P.2016-04-06
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (K160124)Spinevision S.A.2016-04-04
Opticage(R) Expandable Interbody Fusion Device (K160464)Interventional Spine, Inc.2016-04-04
PRECICE Intramedullary Limb Lengthening System (K160325)Ellipse Technologies, Inc.2016-04-04
Premier (K160320)Shandong Weigao Orthopaedic Device Co., Ltd.2016-04-01
PRECICE Trauma Nail System (K160267)Ellipse Technologies, Incorporated2016-03-31
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (K153495)Ldr Spine USA2016-03-31
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing (K151932)Stryker Corporation2016-03-31
JAZZ LOCK (K153348)Implanet, S.A.2016-03-31
Corin TriFit TS Hip (K153772)Corin U.S.A. Limited2016-03-31
SMV Scientific Schanz Screws (K160603)Smv Scientific2016-03-28
ANATOMIC PEEK PTC Cervical Fusion System (K160528)Medtronic Sofamor Danek USA, Inc.2016-03-28
TRYPTIK2C-plate Anterior Cervical Plate System (K153042)Spineart2016-03-28
iTotal Cruciate Retaining (CR) Knee Replacement System (K153721)Conformis, Inc.2016-03-25
SurgTech Interbody System (K152200)Surgtech, Inc.2016-03-25
Corin TaperFit Hip Stem (K153725)Corin U.S.A. Limited2016-03-25
Align Anterior Ankle Fusion Plate (K160191)Extremity Medical, LLC2016-03-25
Optetrak Logic Metaphyseal Cones (K153595)Exactech, Inc.2016-03-25
Biomet Microfixation RibFix Blu Thoracic Fixation System (K152253)Biomet Microfixation2016-03-24
Arthrex SwiveLock Anchors (K151342)Arthrex, Inc.2016-03-24
NuVasive® Lumbar Interbody Implants (K153782)Nu Vasive, Incorporated2016-03-24
TRUESPAN Meniscal Repair System (K153667)Medos International SARL2016-03-24
Cascadia Interbody System (K160547)K2m2016-03-24
X-Fix Line Additions (K151881)Vilex IN Tennessee, Inc.2016-03-24
Response 5.5 Spine System (K160466)OrthoPediatrics Corp.2016-03-23
MPO Total Knee Systems MR Labeling (K152631)Microport Orthopedics, Inc.2016-03-23
Z-Span Plate System (K160362)Zavation, LLC2016-03-22
OS2(R)-VP Varisation Staple (K153770)In2bones Sas2016-03-21
NILE Alternative Fixation Spinal System (K160208)K2m, Inc.2016-03-18
Optetrak Advanced Patella (K160484)Exactech, Inc.2016-03-18
NuVasive® TLX Interbody System (K153627)Nu Vasive, Incorporated2016-03-17
CONQUEST FN (K152686)Smith & Nephew2016-03-17
SUSTAIN Additional Implants (K151665)Globus Medical, Inc.2016-03-16
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (K153250)Renovis Surgical Technologies2016-03-16
SPINAUT-V, SPINAUT-S, SPINAUT-I (K151268)Imedicom Co., Ltd.2016-03-16
Xspan Laminoplasty Fixation System (K160114)X-Spine Systems, Inc.2016-03-15
AOS Anterolateral Proximal Humeral Plate (K160409)Advanced Orthopaedic Solutions, Inc.2016-03-15
UCP Stem (K152530)United Orthopedic Corporation2016-03-14
BellaFuse (K151271)Hans Biomed Corp.2016-03-11
Exactech Vantage Total Ankle System (K152217)Exactech, Inc.2016-03-10
OMNI Skirted Heads (K152919)Omni Life Science, Inc.2016-03-10
Optetrak One Logic Femoral Components (K153776)Exactech, Inc.2016-03-10
Sonoma Fibula Repair System (K160069)Sonoma Orthopedics Products, Inc.2016-03-10
Biomet Variable Pitch Compression Screw System (K160058)Biomet, Inc.2016-03-09
S-Wire (K152662)Spinal Resources, Inc.2016-03-09
Piccolo Composite(R) Distal Volar Radius Plate System (K160002)CarboFix Orthopedics , Ltd.2016-03-09
Erisma-LP Spinal Fixation System (K153326)Clariance, Sas2016-03-08
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System (K160085)Zimmer GmbH2016-03-08
Ventix Knotless Anchors (K152262)Biomet Manufacturing Corp2016-03-08
ProLift Expandable System (K153400)Life Spine, Inc.2016-03-07
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System (K160025)Conformis, Inc.2016-03-07
PERIMETER Interbody Fusion Device (K160418)Medtronic Sofamor Danek USA, Inc.2016-03-07
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020)Captiva Spine2016-03-02
RECON system - Compression Screws (K151708)Normed Medizin-Technik GmbH2016-03-02
PERIMETER C (Titanium) Spinal System (K153438)Medtronic Sofamor Danek USA, Inc.2016-03-02
iFuse Implant System(R) (K152681)SI-BONE, Inc.2016-03-01
Sniper (R) Spine System (K160003)Spine Wave, Inc.2016-02-26
ICONACY(TM) I-Hip (TM) (K151307)Iconacy Orthopedic Implants, LLC2016-02-26
Tyber Medical Trauma Screw (K153575)Tyber Medical, LLC2016-02-26
IRENE Locking Compression Plate System (K151508)Tianjin Zhengtian Medical Instrument Co., Ltd.2016-02-25
SIGN Compression Screw System (K153759)Sign Fracture Care International2016-02-25
Cogent Lateral Interbody System (K151406)Cogent Spine, LLC2016-02-25
SpineView X-Pac Expandable Lumbar Cage System (K152539)Spine View, Inc.2016-02-24
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (K152557)G21, S.R.L.2016-02-23
Arthrex Short Suture Anchors (K151092)Arthrex, Inc.2016-02-23
Palisade Pedicular Fixation System (K153323)Spineology, Inc.2016-02-23
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K153548)Visionsense, Ltd.2016-02-22
Arthrex iBalance TKA System (K153586)Arthrex, Inc.2016-02-19
SmartBase for Arthrex Glenoid IRIS (K153215)Custom Orthopaedic Solutions, Inc.2016-02-19
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems (K153442)Medtronic Sofamor Danek USA, Inc.2016-02-18
OS2-C Compression Staple (K153395)In2bones Sas2016-02-18
Alpine Cemented Hip System (K153216)Ortho Development Corporation2016-02-18
Optimus ALIF System (K160291)Amendia, Inc.2016-02-18
Caspian OCT/MESA Mini/DENALI Mini Spinal System (K153370)K2m, Incorporated2016-02-16
D.N.E. External Fixation System (K151580)Dne, LLC2016-02-16
Zimmer Virage OCT Spinal Fixation System (K153631)Zimmer Spine, Inc.2016-02-16
Adena-Zina System (K152781)Shanghai Sanyou Medical Co, Ltd.2016-02-12
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws (K152187)Merete Medical GmbH2016-02-12
Vitoss BiModal Bone Graft Substitute Foam Strip (K153608)Orthovita, Inc.2016-02-12
C-VBR (K152568)Cardinal Spine, LLC2016-02-11
CD HORIZON Spinal System (K153589)Medtronic Sofamor Danek USA, Inc.2016-02-10
Anterior Cervical Plate System (K151553)Osteomed Implantes, Ltda2016-02-10
Epic Extremity Plate System (K153340)Epic Extremity, LLC2016-02-09
MINIARS SCREWS (K143596)Overmed Srl.2016-02-05
Rampart A Lumbar Interbody Fusion Device (K153082)Spineology, Inc.2016-02-04
The Entasis Dual-Lead Sacroiliac Implant (K152237)Corelink, LLC2016-02-04
Comprehensive SRS/Nexel Elbow (K153398)Biomet Manufacturing Corp2016-02-03
M-Fix Acromioclavicular Device (K153211)Coracoid Solutions, Inc.2016-02-02
In2Bones Kirschner wire (K153204)In2bones Sas2016-02-01
YAHUA Spinal System (K152324)Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.2016-02-01
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System (K153428)Orthofix, Inc.2016-01-29
TriMed Humeral Supracondylar Fixation System (K151735)TriMed, Inc.2016-01-29
PASS OCT Patient Specific Rods (K153169)Medicrea International2016-01-29
COALITION Spacers (K151939)Globus Medical, Inc.2016-01-29
Half Dome Posterior Lumbar Interbody System (K152512)Astura Medical2016-01-28
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