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Orthopedic

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

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RecordFirmDate
Gibralt® Spine System and Gibralt® Occipital Spine System (K160697)Exactech, Inc.2016-06-28
Nanovis Intervertebral Body Fusion System and FortiCore® (K160874)Nanovis, LLC2016-06-28
PressON Pro Spinal Fixation System (K160820)Nexus Spine, LLC2016-06-28
F1 MPS Modular Pedicle Screw System (K160926)Degen Medical2016-06-28
AnyPlus® Cervical PEEK Cage System (K153517)GS Medical Co., Ltd.2016-06-24
SMR Shoulder System (K161476)Lima Corporate S.P.A.2016-06-24
The Life Spine Subtalar Implant System (K160169)Life Spine2016-06-23
FitRite™ Total Hip Arthroplasty System (K153057)Excera Orthopedics, Inc.2016-06-23
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System (K153374)Orthocare2016-06-17
Cervical Stand Alone System (K161280)Orthofix, Inc.2016-06-17
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (K160071)Biomet, Inc.2016-06-16
ZUK Select Knee System (K160738)Smith & Nephew, Inc.2016-06-15
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) (K161366)Conformis, Inc.2016-06-14
BLUEPRINT Patient Specific Instrumentation (K160555)Tornier S.A.S.2016-06-10
Arsenal Spinal Fixation System (K161363)Alphatec Spine, Inc.2016-06-10
Aequalis PerFORM+ Shoulder System (K160975)Tornier, Inc.2016-06-10
NEOVIEW Plating System (K160995)In2bones Sas2016-06-10
ATTUNE Revision Knee System (K160700)Depuy(Ireland)2016-06-10
Lucent Intervertebral Body Fusion Device (K152011)Spinal Elements, Inc.2016-06-09
NuVasive® Reline® System (K160989)Nu Vasive, Incorporated2016-06-09
MILAGRO ADVANCE PEEK Interference Screw (K161001)Medos International SARL2016-06-09
LATERAL Spine Truss System (K153436)4Web, Inc.2016-06-06
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K160775)Choicespine, LP2016-06-03
dynaMX(TM) Nitinol Compression Screw (K160427)Mx Orthopedics, Corp.2016-06-03
Large Screws Range (K160617)Newclip Technics2016-06-03
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (K153131)Signature Orthopaedics Pty, Ltd.2016-06-03
iFUSE Implant System (K160652)SI-BONE, Inc.2016-06-03
OrthoButton CL (K160655)Riverpoint Medical2016-06-03
Corin Optimized Positioning System (OPS) (K152893)Corin USA2016-06-03
Additive Orthopaedics Hammertoe Correction System (K160264)Additive Orthopaedics, LLC2016-06-01
Mariner Pedicle Screw System (K160902)SeaSpine Orthopedics Corporation2016-05-26
AxSOS 3Ti (K153379)Stryker GmbH2016-05-26
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System (K160980)Spineology, Inc.2016-05-26
G7 Dual Mobility System, Active Articulation System (K161190)Biomet, Inc.2016-05-26
ArcadiusXP C Spinal System (K153629)Aesculap Implant Systems, Inc.2016-05-25
PIEZOSURGERY PLUS (K153743)Mectron S.P.A.2016-05-25
Stryker Orthopaedics Hip Systems Labeling Update (K153345)Stryker Orthopaedics2016-05-25
MasterLoc Stem (K160289)Medacta International2016-05-20
Reliance Lumbar IBF System (K160463)Reliance Medical Systems, LLC2016-05-20
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (K153107)Choicespine, LP2016-05-19
EMPOWR PS Knee System (K160342)Encore Medical L.P.2016-05-19
OsteoMed ExtremiLOCK Wrist Plating System (K161041)Osteomed2016-05-19
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector (K160226)Implanet, S.A.2016-05-18
BIOFOAM Bone Wedge (K152062)Wrightmedicaltechnologyinc2016-05-17
GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. (K153716)Gpc Medical, Ltd.2016-05-17
Escalade Legend Acetabular Shell (K161080)Ortho Development Corporation2016-05-17
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (K152754)Biomet Manufacturing Corp2016-05-16
ALTA Anterior Cervical Interbody Spacer (K160154)Astura Medical2016-05-13
Catalyst CSR Shoulder System (K152825)Catalyst Orthoscience, LLC2016-05-11
Vanguard XP Knee System (K153657)Biomet, Inc.2016-05-10
FiberTak DR (K160319)Arthrex, Inc.2016-05-10
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (K152431)Waldemar Link GmbH & Co. KG2016-05-09
NeoFuse HA Enhanced PLIF/TLIF (K153615)Ht Medical, LLC2016-05-06
INVISION Total Ankle Revision System (K153008)Wrightmedicaltechnologyinc2016-05-06
HC Spinal System (K151362)Hung Chun Bio-S Co., Ltd.2016-05-05
Cervical Interbody Fusion System (K160324)Evolution Spine, LLC2016-05-05
Certex Spinal Fixation System (K160428)X-Spine Systems, Inc.2016-05-05
Flip Button Suture Anchor (K153585)First Ray, LLC2016-05-05
Xenco Medical Pedicle Screw System (K160986)Xenco Medical, LLC2016-05-04
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (K153783)Spinevision S.A.2016-05-04
Precision Spine Interspinous Plate System (K160568)Precision Spine, Inc.2016-05-04
ENZA Zero-Profile Anterior Interbody Fusion (K153720)Camber Spine Technologies2016-05-03
STROPP (Single Tunnel Repair of Plantar Plate) (K160118)Crossroads Extremity Systems, LLC2016-05-03
OsteoBullet Compression Screw (K160304)Phalanx Innovations2016-04-29
REVIVAL(TM) Modular Revision Hip Stem (K152903)Corin USA2016-04-29
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug (K152084)Corentec Co., Ltd.2016-04-29
MC-Subtalar(TM) II (K160548)Merete Medical GmbH2016-04-29
Syzygy Stabilization System (K153152)Amendia, Inc.2016-04-27
Pyrenees Cervical Plate System (K153526)K2m2016-04-27
PASS OCT Spinal System (K160756)Medicrea International SA2016-04-26
Inertia Pedicle Screw and Deformity Correxxion System (K153453)Nexxt Spine, LLC2016-04-26
White Pearl Preferred Angle Anterior Cervical Plate (K160522)Osseus Fusion Systems, LLC2016-04-26
Materialise Glenoid Positioning System (K153602)Materialise NV2016-04-26
StarFuse Interphalangeal Pin (K160194)Phalanx Innovations2016-04-26
Genesys Spine Apache Interbody Fusion System (K153123)Genesys Spine2016-04-26
Gridlock Ankle Plating System (K160177)Trilliant Surgical, Ltd.2016-04-22
Cascadia Interbody System (K160125)K2m2016-04-22
G3(TM) Active Plate(R) Small Fragment System (K160633)Genesis Fracture Care, Inc.2016-04-22
PASS LP Spinal System (K153413)Medicrea International SA2016-04-22
Revolution Spinal Fixation System (K160216)Intelligent Implant Systems, LLC2016-04-22
OSTEOPAL plus (K153737)Heraeus Medical GmbH2016-04-22
MotoBand(TM) CP Implant System (K160300)Crossroads Extremity Systems, LLC2016-04-22
Ventix Suture Anchor (K153558)Biomet Manufacturing Corp2016-04-21
Zavation Spinal System (K153404)Zavation, LLC2016-04-21
MaxiGen (K152077)Hans Biomed Corp.2016-04-21
ULTRA Telescopes (K160249)Olympus Winter & Ibe GmbH2016-04-21
NuVasive® Interfixated Interbody System (K160051)Nu Vasive, Incorporated2016-04-20
Elite SPK, Compasso, Elite SPK Kit (K160500)Ncs Lab Srl2016-04-20
Arthrex Univers Revers CA Heads and Adapters (K151527)Arthrex, Inc.2016-04-19
Bicortical Fixation Screw & Washer Nut System (K153638)First Ray, LLC2016-04-19
Leva Spacer System (K153222)Spine Wave, Inc.2016-04-15
Diplomat® Spinal System (K151704)Signus Medizintechnik GmbH2016-04-13
NuVasive CoRoent Thoracolumbar System (K153419)Nu Vasive, Incorporated2016-04-13
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (K143578)Globus Medical, Inc.2016-04-13
Arthrex iBalance BiCompartmental Arthroplasty System (K160461)Arthrex, Inc.2016-04-12
icotec Pedicle System (K151977)Icotec AG2016-04-12
All Poly Tibial Component (K152430)United Orthopedic Corporation2016-04-12
HemiCAP MTP Resurfacing Hemi-Arthroplasty System (K152454)Arthrosurface, Inc.2016-04-11
Hoffmann LRF (Limb Reconstruction Frame) System (K153377)Stryker GmbH2016-04-11
First Ray Internal Bone Staple System (K153622)First Ray, LLC2016-04-08
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