Atlas FDA

Orthopedic

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

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RecordFirmDate
BLUEPRINT Patient Specific Instrumentation (K162800)Tornier S.A.S.2017-02-22
SMR TT Metal Back Glenoid, Bone Graft instruments (K161120)Lima Corporate S.P.A.2017-02-21
AlignMATE™ Lapidus Arthrodesis System (K162391)Arthrosurface, Inc.2017-02-21
VariAx Distal Radius Plating System, VariAx 2 System (K162841)Stryker GmbH2017-02-21
SurgTech Trauma System (K161894)Surgtech, Inc.2017-02-21
Arrowhead Mini-Rail Fixator (K162032)Arrowhead De, LLC2017-02-21
Intra medullary endo-transilluminating device (iMET device) (K163037)WeMED Bio-Tech, Inc.2017-02-17
Z-Span Plate System (K162824)Zavation, LLC2017-02-17
Spine Wave Anterior Cervical Spine System (K162760)Spine Wave, Inc.2017-02-16
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw (K161616)Synthes USA Products, LLC2017-02-16
Kepler I Cervical Plate System (K163602)Orbbo Surgical, LLC2017-02-16
Huvex Interspinous Fixation System (K162849)Dio Medical Co., Ltd.2017-02-16
4CIS® Marlin ACIF Cage System (K162402)Solco Biomedical Co., Ltd.2017-02-16
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE (K161996)Amend Surgical, Inc.2017-02-16
Erisma® LP Spinal Fixation System (K170163)Clariance, Sas2017-02-14
Ultima HA Coated Half Pins and Wire (K163487)Vilex IN Tennessee, Inc.2017-02-13
MCS Bone Graft (K162860)Bioventus, LLC2017-02-13
Revision Femoral Stem (K161226)Lima Corporate S.P.A.2017-02-10
EasyClip Xpress (K162321)Restore Surgical, LLC Dba Instratek2017-02-10
Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (K162697)Custom Orthopaedic Solutions, Inc.2017-02-10
Atlas Spine Expandable Interbody System (K162918)Atlas Spine, Inc.2017-02-09
RASL Repair Kit (K161334)Radicle Orthopaedics, Inc.2017-02-09
DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long (K163046)DePuy Synthes2017-02-09
Hubble I System (K163566)Orbbo Surgical, LLC2017-02-09
APTUS® Coronoid 2.0 (K161861)Medartis AG2017-02-09
Fitmore® Hip Stem (K170072)Zimmer GmbH2017-02-07
Proficient™ Posterior Cervical Spine System (K162639)Spine Wave, Inc.2017-02-07
Altus Spine Cervical Plate System (K163061)Altus Partners, LLC2017-02-06
DCM Kyphoplasty System (K162283)Dragon Crown Medical Co., Ltd.2017-02-06
AxSOS 3 Ti; Stryker Plating System (K162439)Stryker GmbH2017-02-03
ProMIS™ Fixation System (K170061)Premia Spine, Ltd.2017-02-02
HA Minuteman G3-R MIS Fusion Plate (K163428)Spinal Simplicity2017-02-02
Stealth Staple System (K163440)First Ray, LLC2017-02-01
Exactech® Equinoxe® Preserve Stem (K162726)Exactech, Inc.2017-02-01
Life Spine Metatarsal Hemi Implant (K161279)Life Spine, Inc.2017-02-01
Memodyn Staple (K161587)Austin & Associates, Inc./Telos Medical Equipment2017-02-01
U2 Total Knee System, PSA Tibial Insert (K161360)United Orthopedic Corporation2017-02-01
Elite Expandable Interbody Fusion Device (K162879)Spineology, Inc.2017-01-30
FITBONE TAA (K163368)Wittenstein Intens GmbH2017-01-26
ROCCIA® ACIF (K162587)Silony Medical GmbH2017-01-26
ORTHOLOC® 3Di Ankle Fracture Plating System (K163044)Wrightmedicaltechnologyinc2017-01-26
dynaMX™ Compression Plate (K161303)Mx Orthopedics, Corp.2017-01-26
CrossFT Knotless Suture Anchor with Disposable Driver (K163258)Conmed Corporation2017-01-25
PASS LP Spinal System (K162786)Medicrea International SA2017-01-25
Altus Spine Interbody Fusion System (K160976)Altus Partners, LLC2017-01-25
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273)Biomet, Inc.2017-01-25
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K161466)Orthofix Srl2017-01-24
nvc (K170074)Nvision Biomedical Technologies, LLC2017-01-24
AOS Small Bone Nailing System (K163014)Advanced Orthopaedic Solutions, Inc. (Aos)2017-01-24
CONCORD Plus Radiopaque Bone Cement (K162618)Globus Medical, Inc.2017-01-23
Facilis™ Spinal System (K161231)Baui Biotech Co., Ltd.2017-01-23
Anatomic Total Knee System (K161414)Amplitude2017-01-19
JAZZ FRAME SYSTEM (K162764)Implanet, S.A.2017-01-19
NovaBone IRM (K163310)Novabone Products, LLC2017-01-18
GEO Bone Screw System (K161904)Gramercy Extremity Orthopeidics, LLC2017-01-18
Siconus SI Joint Fixation System (K162121)Camber Spine Technologies2017-01-18
SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides (K163156)Materialise NV2017-01-18
Humelock Reversed Shoulder (K162455)Fx Solutions2017-01-17
Legion Cone System (K162775)Smith & Nephew, Inc.2017-01-13
Ayers Rock Cervical interbody fusion system (K162694)Spineway2017-01-12
osteo-WEDGE II ® Open Wedge Bone Locking Plate System (K162179)Graham Medical Technologies, LLC Dba Gramedica2017-01-10
Akros Fibulink Syndesmosis Repair Kit (K162805)Akros Medical2017-01-10
Poseidon OCT Spinal Fixation System (K161637)Medyssey USA, Inc.2017-01-05
LOSPA IS ACP System (K161641)Corentec Co., Ltd.2017-01-05
MOTO Partial Knee System (K162084)Medacta International S.A.2017-01-03
Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table (K162702)Stl International, Inc.2016-12-30
Hubble II (K163180)Orbbo Surgical, LLC2016-12-29
STERISPINE CC (K162531)Safe Orthopaedics2016-12-29
Medline ReNewal Reprocessed Stryker External Fixation Devices (K163028)Surgical Instrument Service and Savings, Inc.2016-12-28
Gexfix External Fixation (K160972)Gexfix International Corp.2016-12-28
BLUEPRINT Patient Specific Instrumentation (K161789)Tornier S.A.S.2016-12-27
The Small PLATEAU (PLATEAU-C) Spacer System (K161127)Life Spine, Inc.2016-12-22
Sphynx™ (K160982)Eden Spine, LLC2016-12-22
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System (K162446)Orthofix, Inc.2016-12-22
neon3™ universal OCT spinal stabilization (K161032)Ulrich GmbH & Co. KG2016-12-22
VLP MINI-MOD 2.0mm Column Plates (K163086)Smith & Nephew, Inc.2016-12-21
IMSE Cervical Cage (K162003)The Institute of Musculoskeletal Science & Education2016-12-21
GMK Revision Femoral Distal Augmentation (K163311)Medacta International S.A.2016-12-21
CD HORIZON® Spinal System (K163301)Medtronic Sofamor Danek USA, Inc.2016-12-20
CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (K160879)Medos International Sàrl2016-12-20
KLS Martin Cannulated Headless Screws (K161259)KLS Martin L.P.2016-12-19
Destiknee Total Knee System (K160771)Meril Healthcare Private Limited2016-12-19
PS2 Knee System (K160515)Consensus Orthopedics, Inc.2016-12-19
CETRA Anterior Cervical Plate System (K162638)Orthofix, Inc.2016-12-16
Arthrex iBalance UKA System Vitamin E Tibial Bearing (K161060)Arthrex, Inc.2016-12-15
ENNOVATE Spinal System (K162134)Aesculap Implant Systems, LLC2016-12-14
Integrity-SI TM Fusion System (K161755)Coorstek Medical2016-12-14
SOVEREIGN® Spinal System (K162680)Medtronic Sofamor Danek USA, Inc.2016-12-14
OXINIUM DH Fermoral Heads (K161233)Smith & Nephew, Inc.2016-12-14
COUGAR® LS Lateral Cage System and COUGAR® System (K162327)Medos International SARL2016-12-12
Biomet Microfixation RibFix Blu Thoracic Fixation System (K162974)Biomet Microfixation2016-12-09
Medline UNITE® Ankle Fracture Plating System (K162829)Medline Industries, Inc.2016-12-09
VIPER PRIME™ additions to the VIPER® System (K162912)Medos International SARL2016-12-08
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System (K162194)Medicrea International SA2016-12-08
OIC Cervical PEEK Spacer (K160222)The Orthopaedic Implant Company2016-12-07
SUTUREFIX Curved Suture Anchor (K163034)Smith and Nephew, Inc.2016-12-07
ShurFit CpTi-HA ACIF Interbody Fusion System (K161809)Precision Spine, Inc.2016-12-06
4.0 and 6.5 Cancellous Bone Screw and Washer (K160946)Smv Scientific2016-12-05
Bencox M Stem Lateralized & Bencox Mirabo Cup System (K162127)Corentec Co., Ltd.2016-12-05
Cerasorb Ortho Foam (K160566)Curasan AG2016-12-02
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