Atlas FDA

Orthopedic

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) (K220374)Medos International SARL2022-03-08
PolyLock Plating System (K211843)Fusion Orthopedics2022-03-04
Exactech® Equinoxe® Laser Cage Glenoid (K212356)Exactech, Inc.2022-03-04
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System (K220379)Medynus, Inc.2022-03-03
Medline UNITE Calcaneal Fracture Plating System (K213567)Medline Industries, LP2022-03-02
Restoration® Modular Hip System (K212187)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-03-01
Blue Topaz Sacroiliac Screw System (K213590)Osseus Fusion Systems, LLC2022-03-01
VyLink™ Spinal Screw System (K213750)Vy Spine, LLC2022-02-28
PRIMA Humeral System and SMR Glenosphere Ø42 (K212800)Lima Corporate S.P.A.2022-02-25
CAPRI Corpectomy Cage System (K211320)K2m, Inc.2022-02-24
Trigon HA Wedge Fixation System (K220197)Nvision Biomedical Technologies, Inc.2022-02-23
Arsenal Ankle Plating System (K212378)Trilliant Surgical2022-02-23
NuVasive Reline Cervical System (K213654)Nu Vasive, Incorporated2022-02-23
True Tulip, True M.I.S. (K212627)Innovative Surgical Designs, Inc.2022-02-18
Traufix osteosynthesis, osteotomy, and arthrodesis devices (K201510)Fixier S.A. DE C.V.2022-02-18
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires (K213982)Pacific Instruments2022-02-17
Treace Medical Concepts (TMC) Plating System (K220136)Treace Medical Concepts, Inc.2022-02-16
LumiVy Lumbar IBF System (K212930)Vy Spine, LLC2022-02-16
Aspiron S ACP System (K220147)U&I Corporation2022-02-16
MAVERICK External Fixation System (K213874)Smith & Nephew, Inc.2022-02-11
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (K213328)Stryker GmbH2022-02-11
3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System (K211712)Orthofix US, LLC2022-02-11
FlexitSystem Knee osteotomy system (K212545)Neosteo2022-02-11
GPC Intraheal Intramedullary Nailing System (K203811)Gpc Medical Limited2022-02-10
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431)Biomet, Inc.2022-02-07
F3D-C2 Cervical Stand-Alone System (K211417)Corelink, LLC2022-02-04
Genex Bone Graft Substitute (K212721)Biocomposites, Ltd.2022-02-04
MectaScrew Extension (K203335)Medacta International S.A.2022-02-03
PALACOS MV pro (K213812)Heraeus Medical GmbH2022-02-02
Exeter® X3® RimFit® Cup (K213701)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-02-01
MIS Precision Chevron Bunion System (K211628)Relja Innovations, LLC2022-01-31
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate (K213489)Wishbone Medical, Inc.2022-01-27
Fortilink with TiPlus Technology (K213493)Paradigm Spine2022-01-27
ANTHEM® Fracture System (K213591)Globus Medical, Inc.2022-01-26
SternaFuse Fixation System (K202914)Fusion Innovations, LLC2022-01-26
PERLA® TL Posterior Osteosynthesis System (K213470)Spineart2022-01-21
b-ONE MOBIO Total Knee System (K213673)B-One Ortho, Corp.2022-01-21
OSSIOfiber® Staple (K212594)OSSIO , Ltd.2022-01-21
Osteorevive (K212991)Bone Solutions, Inc.2022-01-21
Porous Patella (K212941)Encore Medical, L.P. Dba Djo Surgical2022-01-20
GLOBAL ICON Stemless Shoulder System (K212683)Depuy(Ireland)2022-01-19
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (K212581)Stryker GmbH2022-01-19
R3 Large Head Liners (K211330)Smith & Nephew, Inc.2022-01-19
Stern Fix Sternal Stabilization System (K211613)Neos Surgery S.L2022-01-19
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP (K213781)Depuy Ireland UC2022-01-18
JuniOrtho Plating System™ (K213572)Orthofix Srl2022-01-18
BRM TOOL Screws (K203773)Brm Extremities Srl2022-01-14
Distal Humerus Plating System (K213895)Skeletal Dynamics, Inc.2022-01-13
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K212569)Materialise NV2022-01-12
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199)Stryker GmbH2022-01-11
Romero Cervical Cage (K212358)Spineup, Inc.2022-01-10
MagnetOs granules (K213111)Kuros Biosciences B.V2022-01-10
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive (K210198)Gpc Medical Limited2022-01-07
Tesera-k ALIF System (K212980)Kyocera Medical Technologies, Inc.2022-01-07
Pectus Blu Support Bar System (K212841)Biomet Micofixation2022-01-07
Acumed Ankle Syndesmosis Repair System (K212990)Acumed, LLC2022-01-07
Cyclops™ Anterior Cervical Plate System (K213901)Degen Medical2022-01-07
SignaSure Dual Mobility System (K211742)Signature Orthopaedics Pty, Ltd.2022-01-07
DePuy Corail AMT Hip Prosthesis (K213839)DePuy Orthopaedics, Inc.2022-01-06
MPO Knee Instruments; MPO PROPHECY Knee Instruments (K213817)Microport Orthopedics, Inc.2022-01-05
MPO Hip Instruments (K213816)Microport Orthopedics, Inc.2022-01-05
FORZA XP Expandable Spacer System (K213951)Orthofix US, LLC2022-01-05
PRO-DENSE LoVisc Bone Graft Substitute (K213342)Wrightmedicaltechnologyinc2022-01-05
PASS LP™ Spinal System, CD Horizon™ Spinal System (K213281)Medicrea International SA2022-01-05
restor3d Pin Implants (K211789)Restor3D2022-01-04
DynaFuse Fixation System (K203595)MedShape, Inc.2022-01-04
Quick-Start Screws (K212547)Innovate Orthopaedics Limited2021-12-30
Fixone hybrid knotless anchor (K203523)Aju Pharm Co., Ltd.2021-12-25
R3ACT Stabilization System (K211770)Paragon 28, Inc.2021-12-25
NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (K203714)Nu Vasive, Incorporated2021-12-23
Vy Spine™ VyWasher™ Buttress System (K213219)Vy Spine, LLC2021-12-23
Restoration Modular 115mm Conical Distal Stem (K213129)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2021-12-21
FIX-C PEEK Anterior Cervical Interbody System (K212266)Jeil Medical Corporation2021-12-21
InCore Subtalar System (K213301)Nextremity Solutions, Inc.2021-12-21
The Progen™ Trochanteric Nail System (K211086)Ortho Development Corporation2021-12-21
OSSIOfiber Compression Screw, 3.5mm (K213596)OSSIO , Ltd.2021-12-21
Xenco Medical Multilevel CerviKit (K213456)Xenco Medical, LLC2021-12-21
Vy Spine ClariVy Cervical IBF System (K212715)Vy Spine, LLC2021-12-20
Mpact® 3D Metal Implants - DMLS Technology (K202568)Medacta International S.A.2021-12-20
Avenger Radial Head System (K212872)In2bones USA, LLC2021-12-17
Physica system (K213381)Lima Corporate S.P.A.2021-12-17
Arthrex Knotless Mini TightRopes (K213644)Arthrex, Inc.2021-12-17
Balanced Knee System Uni (K211471)Ortho Development Corporation2021-12-16
Activmotion S DTO (K202803)Newclip Technics2021-12-16
Insignia™ Anterior Cervical Plate System (K213443)Alphatec Spine, Inc.2021-12-15
SIMPACT Sacroiliac Joint Fixation System (K212903)Life Spine, Inc.2021-12-15
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (K212781)Spinal Simplicity, LLC2021-12-15
SeaSpine WaveForm C Interbody System (K212904)SeaSpine Orthopedics Corporation2021-12-14
Centerpiece Plate Fixation System (K212428)Medtronic Sofamor Danek2021-12-13
CoLink NeoFuse Plating System (K213069)In2bones USA, LLC2021-12-13
VerSys Cemented Revision/Calcar (K210842)Zimmer, Inc.2021-12-10
Comprehensive Humeral Fracture Positioning Sleeves (K212435)Biomet, Inc.2021-12-10
Vy Spine™ VySpan™ PCT System (K213394)Vy Spine, LLC2021-12-10
Invictus Spinal Fixation System (K213460)Alphatec Spine, Inc.2021-12-10
Medline UNITE REFLEX Dynamic Discs (K211612)Medline Industries, Inc.2021-12-10
LOSPA TKR System (K212034)Corentec Co., Ltd.2021-12-09
Nextra CH Cannulated Hammertoe System (K213530)Nextremity Solutions, Inc.2021-12-09
SeaSpine WaveForm, C Interbody System (K213359)SeaSpine Orthopedics Corporation2021-12-09
Anteralign Spinal System with Titan nanoLOCK Surface Technology (K212524)Medtronic Sofamor Danek USA, Inc.2021-12-08
ShurFit Lumbar Interbody System (K212075)Precision Spine, Inc.2021-12-08
← Previous Next →

Track Orthopedic automatically

Every clearance here is in the API, with alerts when new ones post.