Atlas FDA

Orthopedic

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

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RecordFirmDate
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (K190655)SeaSpine Orthopedics Corporation2019-04-29
InterSpace Knee Extra-Large Size, InterSpace Knee ATS (K181732)Tecres S.P.A.2019-04-27
AltiVate Reverse Humeral Stem, 48mm (K190290)Encore Medical L.P.2019-04-26
CyclaPlex Correction System (K183094)Cycla Orthopedics, Ltd.2019-04-26
Parcus ATLAS (K190375)Parcus Medical, LLC2019-04-24
NanoBone SBX PUTTY, NanoBone QD (K190110)Artoss GmbH2019-04-23
Comprehensive Nano Stemless Shoulder (K182516)Biomet Manufacturing Corp2019-04-22
ASSURE® Anterior Cervical Plate System (K183056)Globus Medical, Inc.2019-04-19
ATLAS Plating System (K190415)MiRus, LLC2019-04-19
CancelleX Porous Titanium Lumbar Interbody Device (K190364)Xenco Medical, LLC2019-04-18
Arthrex 2.5 mm Tenodesis Screw (K183395)Arthrex, Inc.2019-04-17
Arthrex SwiveLock Anchors (K190728)Arthrex, Inc.2019-04-17
Baby Gorilla/Gorilla Plating System (K190365)Paragon 28, Inc.2019-04-12
MIS Bunion Plating System (K190658)Crossroads Extremity Systems, LLC2019-04-12
Syntec Femoral Nail System (K181296)Syntec Scientific Corporation2019-04-11
Zavation Spinal System (K190317)Zavation Medical Products, LLC2019-04-11
M.U.S.T. MINI Posterior Cervical Screws System (K190631)Medacta International S.A.2019-04-10
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® (K182375)Globus Medical, Inc.2019-04-08
OIC External Fixation System (K183682)Orthopaedic Implant Company2019-04-08
Vitality® Spinal Fixation System (K183550)Zimmer Biomet Spine, Inc.2019-04-08
MEDINAUT Plus (K182287)Imedicom Co., Ltd.2019-04-06
CROSSWAY Spinal Access System (K190598)Globus Medical, Inc.2019-04-05
VERTEX Nitinol Staple System (K182943)Nvision Biomedical Technologies, LLC2019-04-04
PYRAMESH™ Implant System (K183197)Medtronic Sofamor Danek USA, Inc.2019-04-04
Monster® Screw System (K190586)Paragon 28, Inc.2019-04-03
iFuse Implant System® (K190230)SI-BONE, Inc.2019-04-03
Karma® Fixation System (K190289)Spinal Elements, Inc.2019-04-03
LINK GEMINI SL Total Knee System (K182872)Waldemar Link GmbH & Co. KG2019-04-03
CONCORDE LIFT (K182349)Medos International SARL2019-04-03
FlareHawk Interbody Fusion System (K183184)Integrity Implants, Inc.2019-04-03
Zimmer Biomet Ceramic Heads (K181171)Zimmer, Inc.2019-04-02
Bencox Mirabo Cup Multi Hole (K182221)Corentec Co., Ltd.2019-04-01
Vantage Total Ankle Flat Cut Talar Components (K183343)Exactech, Inc.2019-04-01
Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly (K183596)Total Joint Orthopedics, Inc.2019-03-29
LOADPRO™ Intraoperative Rod Strain Sensor (DEN180012)Intellirod Spine, Inc.2019-03-28
Responsive Arthroscopy Wedge Push-In Suture Anchors (K190446)Responsive Arthroscopy, LLC2019-03-27
Arthrex TensionLoc System (K183628)Arthrex, Inc.2019-03-26
MUTARS Proximal Femur Replacement System (K181778)Implantcast GmbH2019-03-25
OsteoCentric Bone Plate and Screw System (K190430)Osteocentric Trauma2019-03-22
MPACT Extension (K183582)Medacta International S.A.2019-03-21
NuVasive® VersaTie® System (K190418)Nu Vasive, Incorporated2019-03-21
nvc (K190380)Nvision Biomedical Technologies, Inc.2019-03-21
CastleLoc-P Anterior Cervical Plate System (K190425)L&K BIOMED Co., Ltd.2019-03-21
Mineral Collagen Composite Bioactive Moldable (K182074)Collagen Matrix, Inc.2019-03-21
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (K182468)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019-03-19
Zavation Spinal System (K190361)Zavation Medical Products, LLC2019-03-18
Paradigm All-Suture Anchor 1.8mm, White/Black #2 (K190333)Conmed Corporation2019-03-18
The Progressive Orthopaedic Company Total Knee System II (K183344)The Progressive Orthopaedic Company, LLC2019-03-18
MectaLIF Anterior Stand Alone Extension (K183426)Medacta International S.A.2019-03-15
Parcus Twist AP Suture Anchors (K183501)Parcus Medical, LLC2019-03-15
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly (K190280)Total Joint Orthopedics, Inc.2019-03-15
PROSTIM Injectable Inductive Graft (K190283)Wrightmedicaltechnologyinc2019-03-14
EUROPA Pedicle Screw System (K180337)MiRus, LLC2019-03-14
MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) (K182920)MiRus, LLC2019-03-13
Wright Jones Fracture System (K183026)Wrightmedicaltechnologyinc2019-03-13
Alteon Acetabular Cup System (K182502)Exactech, Inc.2019-03-13
Modular Spinal Fixation System (K183430)Life Spine, Inc.2019-03-13
ISS-JAZZ Screw System and JAZZ CAP SP (K182771)Implanet, S.A.2019-03-12
INnate Cannulated Screw System (K183603)Exsomed Corporation2019-03-12
ActivOrtho Nitinol Compression Screw System (K181610)Activortho, Inc.2019-03-12
Double ENDOBUTTON Fixation Device (K183232)Smith and Nephew, Inc.2019-03-12
Rotium Bioresorbable Wick (K183236)Nanofiber Solutions, LLC2019-03-11
EVOS Small Fragment Upper Extremity Plates Line Additions (K190253)Smith & Nephew, Inc.2019-03-11
Kuros TLIF Cage (K183092)Kuros Biosciences B.V2019-03-08
Provident II Hip Stem (K190276)Stelkast, Inc.2019-03-08
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads (K182799)Arthrex, Inc.2019-03-08
CORUS Spinal System (K190201)Providence Medical Technology, Inc.2019-03-08
Spectrum Spine Expandable Cages (SSEC) (K173518)Spectrum Spine, LLC2019-03-07
Duo Lumbar Interbody Fusion Device (K190055)Spineology, Inc.2019-03-07
ChoiceSpine Stealth Cervical Spacer System (K183397)Choicespine, LP2019-03-06
Stryker SternalPlate System (K183172)Stryker2019-03-05
MLP Special Locking Bone Plate System (K181843)Maxxion Medical, LLC / Baumer SA2019-03-04
SCARLET® AC-T Secured Anterior Cervical Cage (K190322)Spineart2019-03-04
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices (K190193)Spineex, Inc.2019-03-04
Tenodesis Screw System (K183690)Paragon 28, Inc.2019-03-01
CurvaFix Intramedullary Rodscrew System (K180050)Curvafix, Inc.2019-03-01
Idys™ TLIF TiVac (K183259)Clariance, Sas2019-03-01
IdentiTi Porous Ti Interbody System (K183705)Alphatec Spine, Inc.2019-03-01
Austin Miller Large External Fixation System (K181528)Austin Miller Trauma, LLC2019-02-28
HEALIX ADVANCE SP PEEK Anchor (K182941)Medos International SARL2019-02-26
Perla® Posterior Cervico-Thoracic Fixation System (K190071)Spineart2019-02-25
Altus Spine Interbody Fusion System (K182406)Altus Partners, LLC2019-02-22
Libertas Acetabular Hooded Liner (K183365)Maxx Orthopedics, Inc.2019-02-22
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System (K183588)Choicespine2019-02-22
HEALIX Ti ANCHOR with DYNACORD (K183279)Medos International SARL2019-02-21
MIS Bunion System (K181872)Crossroads Extremity Systems, LLC2019-02-19
Vector Hammertoe Correction System (K183055)Nvision Biomedical Technologies, LLC2019-02-19
TEMA Elbow System (K181362)Lima Corporate S.P.A.2019-02-16
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K183039)Stryker GmbH2019-02-15
Reliance Lumbar IBF System (K183049)Reliance Medical Systems, LLC2019-02-15
Stabil Orthopaedic Solutions Total Knee System (K183225)Stabil Orthopaedic Solutions, LLC2019-02-15
HEALIX ADVANCE Anchor with DYNACORD Suture (K183506)Medos International SARL2019-02-14
DynaNail Mini (K182677)MedShape, Inc.2019-02-14
Shoreline Cervical Interbody RT System (K183083)SeaSpine Orthopedics Corporation2019-02-14
AdvantageRib System (K183317)Sig Medical Corporation2019-02-14
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups (K182705)B-One Ortho, Corp.2019-02-14
NuVasive Reline System (K182974)Nu Vasive, Incorporated2019-02-13
EPIC Extremity Fusion Plate System (K182991)Epic Extremity, LLC2019-02-13
Journey II Unicompartmental Knee System (K190085)Smith & Nephew, Inc.2019-02-11
Athena II Cervical Plate System (K183409)Medyssey USA, Inc.2019-02-11
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