Atlas FDA

Orthopedic

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

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RecordFirmDate
Medacta Shoulder System (K192967)Medacta International S.A.2020-03-25
SEA-LINK Anterior Cervical Plate System (K200224)Indius Medical Technologies Pvt. , Ltd.2020-03-24
Persona Personalized Knee System (K200209)Zimmer, Inc.2020-03-24
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System (K193100)OrthoPediatrics Corp.2020-03-24
NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (K200543)Nexxt Spine, LLC2020-03-23
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (K200043)Field Orthopaedics Pty, Ltd.2020-03-23
Sternal Cable System (K193479)A & E Medical Corporation2020-03-23
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (K191788)Medtronic Sofamor Danek USA, Inc.2020-03-23
icotec Cervical Cage (K192897)Icotec AG2020-03-20
T2 ICF (K193366)Stryker GmbH2020-03-20
Nano FortiFix® System (K193211)Nanovis Spine, LLC2020-03-20
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner (K193560)Materialise NV2020-03-20
CPT Hip System (K191735)Zimmer, Inc.2020-03-20
G3 40 Radiopaque Bone Cement (K193061)G21, S.R.L.2020-03-19
G1 40 Radiopaque Bone Cement (K193059)G21, S.R.L.2020-03-19
restor3d Metallic Interference Screw (K193491)Restor3D2020-03-19
Park's Pectus System (K191057)Tdm Co., Ltd.2020-03-19
HEALICOIL Knotless Suture Anchors (K193558)Smith & Nephew, Inc.2020-03-18
LINK TrabecuLink Tibial Cones (K200113)Waldemar Link GmbH & Co. KG2020-03-18
iBalance UKA Tibial Tray Implant (K200433)Arthrex, Inc.2020-03-17
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill (K200151)Zimmer, Inc.2020-03-17
Response BandLoc Spinal Fixation (K200097)OrthoPediatrics Corp.2020-03-16
3DMetal Diaphyseal Femoral Cones (K200075)Medacta International S.A.2020-03-13
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System (K193105)Conformis, Inc.2020-03-13
LEGION Inserts with JRNY Lock (K200407)Smith & Nephew, Inc.2020-03-13
SeaSpine Skipjack System (K193418)SeaSpine Orthopedics Corporation2020-03-13
Arthrex FiberTak Suture Anchor (K200341)Arthrex, Inc.2020-03-12
Tritium Sternal Cable Plate System (K193468)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-03-12
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K200328)Kyocera Medical Technologies, Inc.2020-03-11
KLS Martin Individual Patient Solutions (IPS) Planning System (K192979)KLS-Martin L.P.2020-03-11
Fixone Biocomposite Anchor (K192484)Aju Pharm Co., Ltd.2020-03-11
Apollo Suture Anchor System (K192810)Valeris Medical2020-03-11
MectaLIF Anterior Simple (K200048)Medacta International S.A.2020-03-09
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant (K190652)OSSIO , Ltd.2020-03-06
MEGAFIX® Pedicle Screw Spinal System (K191655)Seohancare Co., Ltd.2020-03-06
LOSPA® IS™ Spinal Fixation System (K200267)Corentec Co., Ltd.2020-03-06
V-STRUT Vertebral Implant (K191709)Hyprevention Sas2020-03-05
ALLthread PEEK Suture Anchor (K193402)Biomet, Inc.2020-03-05
Coronet Soft Tissue Fixation System (K200028)Conextions Medical2020-03-04
KinematX Total Wrist Arthroplasty System (K191525)Extremity Medical, LLC2020-03-04
ARIX Ankle System (K193616)Jeil Medical Corporation2020-03-04
Mecta-C Stand Alone (K192906)Medacta International S.A.2020-03-04
Fixone Biocomposite Small Anchor (K192032)Aju Pharm Co., Ltd.2020-03-03
CarboClear Lumbar Cage System (K193378)CarboFix Orthopedics , Ltd.2020-03-02
Anjon Bremer Halo System (K193256)Anjon Holdings, LLC2020-03-02
Atlas Spine Expandable Cervical Standalone Interbody System (K192570)Atlas Spine, Inc.2020-02-28
Zimmer M/L Taper Hip Prosthesis (K192660)Zimmer, Inc.2020-02-28
Daytona® Small Stature Spinal System (K200381)SeaSpine Orthopedics Corporation2020-02-28
CONQUEST FN (K193029)Smith & Nephew, Inc.2020-02-28
Superelastic Staple (K192447)Neosteo2020-02-28
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads (K192683)Biomet UK, Ltd.2020-02-27
Omnia Medical Trauma Screws (K192096)Omnia Medical, LLC2020-02-27
Pitkar Locked Plating System (K192619)S.H.Pitkar Orthotools Pvt. , Ltd.2020-02-27
DePuy Synthes Hammertoe Continuous Compression Implant (K191463)Synthes (USA) Products, LLC2020-02-26
NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System (K193506)Nu Vasive, Incorporated2020-02-26
Trigon HA Stand-Alone Wedge Fixation System (K193414)Nvision Biomedical Technologies, Inc.2020-02-25
DELTA XTEND(TM) Reverse Shoulder System (K192855)Depuy(Ireland)2020-02-24
Alliance Augmented Glenoid (K193180)Zimmer, Inc.2020-02-24
Titanium Interference Screws (K193451)Biomet, Inc.2020-02-24
NEXXT MATRIXX System (K193412)Nexxt Spine, LLC2020-02-24
T2 Alpha Tibia Nailing System, IMN Screws System (K193308)Stryker Trauma GmbH2020-02-23
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage (K190363)Omnia Medical, LLC2020-02-21
Glenoid Baseplate with Screw (K192799)Fx Shoulder USA, Inc.2020-02-21
Largo PEEK Interbody System (K193255)Flospine, LLC2020-02-20
Exactech® Equinoxe® Reverse Shoulder Glenospheres (K193098)Exactech, Inc.2020-02-20
WIN Flexible Nail System (K193533)Biomet, Inc.2020-02-20
MOJAVE Expandable Interbody System (K193203)K2m, Inc.2020-02-18
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System (K193554)Medartis AG2020-02-16
Dunamis PunchTac Suture Anchors (K193245)Dunamis, LLC2020-02-14
NewPrim System (K191966)Brm Extremities2020-02-13
Daytona® Small Stature Growth Rod Conversion Set (K193224)SeaSpine Orthopedics Corporation2020-02-13
Agilon Moldable (K193168)Biogennix, LLC2020-02-13
OrthoCircle Spine Pedicle Screw System (K193472)Orthocircle Spine2020-02-13
Arthrex Mini Comprehensive Fixation System - 1.0mm Screws (K193156)Arthrex, Inc.2020-02-10
M.U.S.T. MINI Posterior Cervical Screws System (K200130)Medacta International S.A.2020-02-10
MectaFix CL Fixation Button with Continuous Loop (K193165)Medacta International S.A.2020-02-10
Yukon OCT Spinal System (K193129)K2m, Inc.2020-02-07
Steerable Plateau Ti (K193521)Life Spine, Inc.2020-02-06
MectaLock All-Suture Anchors (K193461)Medacta International S.A.2020-02-06
PERLA® TL posterior osteosynthesis system (K193396)Spineart2020-02-05
SpineNet SSP System (K200170)Spinenet, LLC2020-02-05
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System (K193320)Kyocera Medical Technologies, Inc.2020-02-04
Summit DuoFix HA Coating (K193398)DePuy Orthopaedics, Inc.2020-02-04
Comus Locking Plate systems (K190842)Jiangsu Trauhui Medical Instrument Co., Ltd.2020-02-03
CapLOX II®/TowerLOX® MIS Pedicle Screw System (K193270)Captiva Spine, Inc.2020-01-31
TTC Phantom® Intramedullary Nail System (K192163)Paragon 28, Inc.2020-01-31
Physica LMC Knee System (K193284)Lima Corporate S.P.A.2020-01-31
ProLift Expandable System (K193258)Life Spine, Inc.2020-01-31
ATTUNE All-Polyethylene Tibia (K193057)Depuy Ireland UC2020-01-30
SCS 17-01 (K190956)Anika Therapeutics, Inc.2020-01-30
Anatomical Shoulder System (K193099)Zimmer GmbH2020-01-29
Quantum® Total Ankle Prosthesis (K191380)In2bones Sas2020-01-29
MectaTap TI Suture Anchor (K191677)Medacta International S.A.2020-01-29
M.U.S.T. Pedicle Screw System (K193365)Medacta International S.A.2020-01-27
APTUS Clavicle System (K192984)Medartis AG2020-01-24
SYPMHONY™ OCT System (K192014)Medos International SARL2020-01-24
Paratrooper Plantar Plate Repair System (K191227)Paragon 28, Inc.2020-01-24
Persona Personalized Knee System (K193223)Zimmer, Inc.2020-01-24
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor (K193295)Parcus Medical, LLC2020-01-23
SCARLET AL-T (K192993)Spineart2020-01-22
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