Atlas FDA

Orthopedic

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

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RecordFirmDate
VersaTap, VersaLat, DueLock, VersaTi, MiniTi (K212381)Ortho-Design (Pty), Ltd.2021-12-06
CHENA-C Spacer System (K213115)Kahtnu Surgical, Inc.2021-12-06
Inspan ScrewLES Fusion System (K213266)Lespine Innovations, LLC2021-12-03
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (K213580)Total Joint Othopedics, Inc.2021-12-03
NGM WAVE PLIF Cage (K212050)NGMedical GmbH2021-12-01
ARROW Short Stem Humeral System (K202024)FH Industrie2021-11-30
3D-Cut (K212237)3D-Side S.A.2021-11-29
Xpert Wrist (K213214)Newclip Technics2021-11-24
The Radian MIS Bunion System (K211650)Nvision Biomedical Technologies, Inc.2021-11-24
Vector® Hammertoe Correction System (K213421)Nvision Biomedical Technologies, Inc.2021-11-19
Velofix SA Cervical Cage (K210573)U&I Corporation2021-11-19
Catalyft LS Expandable Interbody System (K212653)Medtronic Sofamor Danek USA, Inc.2021-11-19
CoLink Vallux Plating System (K212487)In2bones USA, LLC2021-11-18
Stratum® Ankle Fusion Plating System (K212640)Nextremity Solutions, Inc.2021-11-18
LINK® Embrace Shoulder System - Reverse Configuration (K212992)Waldemar Link GmbH & Co. KG2021-11-18
Arthrex Modular Glenoid System-Titanium Glenosphere (K212415)Arthrex, Inc.2021-11-17
Sterile PHALINX Hammertoe System (K212996)Wrightmedicaltechnologyinc2021-11-16
Opulent TiNbN Coated Knee (K212839)Meril Healthcare Pvt. , Ltd.2021-11-16
MOTOTM Partial Knee & MOTO PFJ Systems Extension (K213071)Medacta International S.A.2021-11-16
Deploy Expandable Interbody System (K211845)Southern Spine, LLC2021-11-16
Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation (K211359)Tornier, Inc.2021-11-12
VSP® Orthopedics System (K211244)3D Systems2021-11-10
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System (K213389)Conformis, Inc.2021-11-10
BESPA Charcot System (K202326)Bespa Global, LLC2021-11-09
Paragon 28 External Ring Fixation System (K212895)Paragon 28, Inc.2021-11-08
TrueLok Evo (K212044)Orthofix Srl2021-11-05
Cervical Stand-Alone System (K212853)Eminent Spine, LLC2021-11-05
Comprehensive® Convertible Glenoid - Vivacit-E Liner (K211729)Biomet Manufacturing Corp2021-11-04
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System (K212912)B-One Ortho, Corp.2021-11-04
Dakota ALIF Plate System (K212937)Precision Spine, Inc.2021-11-04
NuVasive Anterior Cervical Plate Systems (K212446)Nu Vasive, Incorporated2021-11-03
DePuy CONDUIT LLIF Angled Inserters (K212823)Enztec Limited2021-11-01
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF (K212389)Intelivation, LLC2021-10-29
MectaLIF Extension (K212831)Medacta International S.A.2021-10-29
TRACKER Plus Kyphoplasty System (K211797)GS Medical Co., Ltd.2021-10-28
BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489)Neo Medical SA2021-10-28
Tomier Perform™ Reversed Glenoid Cannulated Glenospheres (K213124)Tornier, Inc.2021-10-26
Quantum Anterior Cervical Plate (K210424)Nvision Biomedical Technologies, Inc.2021-10-22
Treace Medical Concepts (TMC) Screw Fixation System (K213036)Treace Medical Concepts, Inc.2021-10-21
LOQTEQ Proximal Humerus Plate 3.5 System (K211582)Aap Implantate AG2021-10-18
AxTiHA Stand-Alone ALIF System (K212967)Innovasis, Inc.2021-10-15
CORUS Spinal System-X (K212636)Providence Medical Technology, Inc.2021-10-15
BC Reflex Uni Knee System (K212307)Bodycad Laboratories, Inc.2021-10-12
Signature™ ONE System (K212560)Orthosoft Inc (D/B/A Zimmer Cas)2021-10-12
Correx Software (K212552)Vilex, LLC2021-10-12
Idys-C ZP 3DTi (K212562)Clariance, SA2021-10-12
ABCcolla Bone Matrix (K212156)Acro Biomedical Co., Ltd.2021-10-08
ProLift Micro Expandable Spacer System (K212520)Life Spine, Inc.2021-10-08
ActiFlip (K212739)Parcus Medical, LLC2021-10-06
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System (K203002)Bonebridge AG2021-10-05
Steinmann Pins and Kirschner Wires (K211508)Stryker GmbH2021-10-05
ChM 4.5mm Cortical screws (K210490)Chm Sp. Z O.O.2021-10-05
Dry DBM- A Putty (K212135)Seaspine Corporation2021-10-04
Porous Patella and Porous Tibia Baseplate (K211221)Smith & Nephew, Inc.2021-10-01
Anthem Fracture System (K212433)Globus Medical, Inc.2021-10-01
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (K200011)Microport Orthopedics, Inc.2021-10-01
Small Bone Nailing System (K211439)Skeletal Dynamics, Inc.2021-09-30
ORIO-Ti Intervertebral Body Fusion Cage System (K211935)Spinecraft, LLC2021-09-30
EMERGE™ Anterior Cervical Plate System (K212405)Evolution Spine2021-09-30
Axis Spine Technologies ALIF (K210590)Axis Spine Technologies, Ltd.2021-09-29
DualX (K211740)Amplify Surgical, Inc.2021-09-29
Persona® Personalized Knee System (K212129)Zimmer Switzerland Manufacturing GmbH2021-09-28
Encore Hip Stem (K211505)Signature Orthopaedics Pty, Ltd.2021-09-24
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K212792)Medynus, Inc.2021-09-23
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K212411)Conformis, Inc.2021-09-23
Nexta PEEK Hammertoe Correction System (K211996)Nextremity Solutions, Inc.2021-09-23
DB-EZ Bone Void Filler (K212353)Dimensional Bioceramics, LLC2021-09-22
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System (K211805)Alphatec Spine, Inc.2021-09-22
Mpres Neck Preserving Stem (K210263)Medacta International S.A.2021-09-22
GEO Extremity and Ankle Plating System (K212334)Gramercy Extremity Orthopedics, LLC2021-09-21
Mariner Pedicle Screw System (K212692)SeaSpine Orthopedics Corporation2021-09-21
KEYSTONE PEEK Cage System (K211689)Shanghai Sanyou Medical Co, Ltd.2021-09-21
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating (K212742)Waldemar Link GmbH & Co. KG2021-09-16
VISIONAIRE UK Patient Matched Cutting Guides (K211512)Smith & Nephew, Inc.2021-09-16
GLOBAL UNITE™ Platform Shoulder System (K212710)Depuy Ireland UC2021-09-15
mi-eye 3 needlescope with cannula, mi-tablet 3 (K212556)Trice Medical, Inc.2021-09-15
Kleiner KG2 System (K211474)BAAT Medical Products B.V.2021-09-14
EDEN Peek Cage (K201793)Jmt Co., Ltd.2021-09-13
Explorer TO System (K212540)SeaSpine Orthopedics Corporation2021-09-10
Curiteva Sacroiliac Joint Fusion System (K210402)Curiteva, Inc.2021-09-09
OneLIF Intervertebral Body Replacement System (K211769)Novapproach Spine2021-09-07
C-CURVE Interbody Fusion Device (K210470)Medicrea International SA2021-09-03
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K210861)Stryker GmbH2021-09-03
MagnetOs Easypack Putty (K211201)Kuros Biosciences B.V2021-09-02
Univers Revers Modular Glenoid System, Standard Augment Baseplates (K211074)Arthrex, Inc.2021-09-02
Admiral ACP System (K212139)SeaSpine Orthopedics Corporation2021-09-01
EndoLIF Delta-Cage and DoubleWedge-Cage (K203014)Joimax GmbH2021-09-01
Triton™ Sacroiliac Joint Fixation System (K211449)Choice Spine, LLC2021-08-31
Tactoset Injectable Bone Substitute (K212083)Anika Therapeutics, Inc.2021-08-31
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System (K211704)Orthofix, Inc.2021-08-31
KMTI S141 Lumbar Interbody Fusion System (K212070)Kyocera Medical Technologies, Inc.2021-08-30
Paratrooper Plantar Plate Repair System (K211322)Paragon 28, Inc.2021-08-30
Impulse AM Interbody Fusion System (K210090)Degen Medical2021-08-30
Shoreline Threaded TruProfile® Plate (K211903)SeaSpine Orthopedics Corporation2021-08-30
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (K210122)Osteonic Co., Ltd.2021-08-27
BEE PLIF Cage (K211413)NGMedical GmbH2021-08-27
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K212038)K&J Consulting Corporation2021-08-27
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System (DEN200064)Canary Medical, Inc.2021-08-27
Auxein Nailing System (K210792)Auxein Medical Private Limited2021-08-25
Lateralized and Augmented Baseplates (K210790)Fx Shoulder USA, Inc.2021-08-25
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