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Orthopedic

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

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RecordFirmDate
Synthetic Bone Putty (K221644)Ventris Medical2022-09-02
Bonebridge Osteosynthesis Plating System (K213864)Bonebridge AG2022-09-02
StageOne Knee Cement Spacer Molds (K213287)Biomet, Inc.2022-09-02
INHANCETM Reverse Glenoid Peripheral Posts (K221467)Depuy Ireland UC2022-08-31
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (K210935)I.T.S. GmbH2022-08-31
Sterile Posterior Spinal Fixation System (K221745)Shanghai Reach Medical Instrument Co, Ltd.2022-08-31
Salvo® Spine System (K222362)Spine Wave, Inc.2022-08-29
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (K220875)Innovasis, Inc.2022-08-26
LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation (K222278)Corentec Co., Ltd.2022-08-26
Arthrex Self Punching SwiveLock Suture Anchors (K222263)Arthrex, Inc.2022-08-26
BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (K222256)Neo Medical SA2022-08-26
Acute QC Strut and Components (K221792)Smith & Nephew, Inc.2022-08-25
CONDUIT Lateral Switch Plate (K221325)Medos International SARL2022-08-25
ONX Large External Fixation System (K213905)Orthonovis, Inc.2022-08-25
ARIX Small Fragment System (K221920)Jeil Medical Corporation2022-08-24
GMK 3D Metal Tibial Tray (K221850)Medacta International S.A.2022-08-23
FIBERGRAFT Aeridyan Matrix Bone Graft Substitute (K213803)Prosidyan, Inc.2022-08-23
Arthrex FiberTape and TigerTape Cerclage Sutures (K221485)Arthrex, Inc.2022-08-22
Auxilock Draw Tight Suture-Based Anchor (K213109)Auxein Medical Private Limited2022-08-22
uCerv Flux-C 3D Porous Titanium Cervical Interbody (K220696)Ulrich Medical USA2022-08-19
DynaClip® Bone Staple (K220812)MedShape, Inc.2022-08-19
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848)Centinel Spine, LLC2022-08-19
Baby Gorilla®/Gorilla® Plating System (K222194)Paragon 28, Inc.2022-08-19
Cortera Spinal Fixation System (K221403)Surgalign Spine Technologies2022-08-19
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (K221023)Spinal Simplicity, LLC2022-08-19
OR3O Dual Mobility System (K220959)Smith & Nephew, Inc.2022-08-18
implaFit® hip stems (K210678)Implantcast GmbH2022-08-17
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K220452)Materialise NV2022-08-17
TDM Lumbar Interbody Fusion Cage System (K221844)Tdm Co., Ltd.2022-08-17
FairFix Adjustable Button System (K222169)Medacta International S.A.2022-08-16
Zavation VariSync Plate System and VariSync Spacer System (K221049)Zavation Medical Products, LLC2022-08-12
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (K222082)Carlsmed, Inc.2022-08-12
Arthrex Knotless FiberTak Biceps Suture Anchor (K222161)Arthrex, Inc.2022-08-11
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (K220731)Stryker2022-08-11
NextGen Pedicle Screw System (K221776)Corelink, LLC2022-08-09
Unispace SA Cervical Cage (K213791)Edisoninno Co., Ltd.2022-08-05
CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614)Centermed, Inc.2022-08-04
Actera™ hip system (K221104)Conformis, Inc.2022-08-04
Cannulated Screws (K213614)Maxxion Medical, LLC2022-08-03
Auxilock Titanium Screw-In Suture Anchor (K213104)Auxein Medical Private Limited2022-07-29
S-Core Implant System (K220901)Subchondral Solutions, Inc.2022-07-29
INERTIA CONNEXX Modular Pedicle Screw System (K221905)Nexxt Spine, LLC2022-07-28
OsteoCentric Spine MIS Pedicle Fastener System (K221332)OsteoCentric Technologies2022-07-28
KeriFlex® MCP and PIP Finger Joint Prostheses (K211385)Keri Medical SA2022-07-27
Pegasus-X Expandable PLIF System (K221687)GS Medical Co., Ltd.2022-07-27
TransLoc 3D (K211496)Foundation Fusion Solutions, LLC (Dba Cornerloc)2022-07-27
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K221404)Conformis, Inc.2022-07-26
Parcus Synd-EZ SS (K221502)Parcus Medical, LLC2022-07-26
Cemented Round Patella with JRNY Pegs (K221939)Smith & Nephew, Inc.2022-07-26
VyPlate Anterior Cervical Plate System (K221572)Vy Spine, LLC2022-07-26
Kentrospine PSS Pedicle Screw System (K220486)Rivarp Medical Private Limited2022-07-22
DM Converter - TiN coated (K211891)Medacta International S.A.2022-07-22
SECURE-LOCK (K220906)Xiros, Ltd.2022-07-22
C-Stem AMT LE Prosthesis (K220216)Depuy Ireland UC2022-07-22
Align Lumbar Interbody Fusion System (K221535)Acuity Surgical Devices, LLC2022-07-22
Pediatric Nailing Platform Femur (K220679)OrthoPediatrics Corp.2022-07-20
Vario-Cup System (K221794)Waldemar Link GmbH & Co. KG2022-07-20
Mitek TIGHT-N Anchor (K221364)Medos International SARL2022-07-11
ZIP™ MIS Interspinous Fusion System (K221399)Aurora Spine, Inc.2022-07-08
Stryker VariAx 2 MIS Calcaneus (K221346)Stryker GmbH2022-07-08
AltiVate® Anatomic Shoulder AG e+™ with Markers (K213387)Encore Medical L.P.2022-07-07
My3D® Personalized Pelvic Reconstruction (K212815)Onkos Surgical2022-07-06
Materialise TKA Guide System (K221337)Materialise NV2022-07-05
Smith & Nephew Hip Systems (K211176)Smith & Nephew, Inc.2022-07-01
Ennovate Cervical Spinal and Occiput System (K213871)Aesculap Implant Systems, LLC2022-07-01
Footmotion Plating System (K221395)Newclip Technics2022-07-01
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (K221050)Aegis Spine, Inc.2022-06-30
Arthrex Mini Fragment System (K220937)Arthrex, Inc.2022-06-29
Mg OSTEOINJECT (K221256)Bone Solutions, Inc.2022-06-28
OsteoProbe (K221195)Active Life Scientific, Inc.2022-06-28
Patient Specific Marking Guides (K211076)Additive Orthopaedics, LLC2022-06-28
Venus Cervical Plate System (K211718)Artfx Medical, LLC2022-06-28
DePuy CONDUIT LLIF SQUID Inserter (K220449)Enztec Limited2022-06-28
T-FIX® 3DSI Joint Fusion System (K214123)Cutting Edge Spine, LLC2022-06-24
EDEN Spinal Fixation System (K201788)Jmt Co., Ltd.2022-06-23
Catalyst R1 Reverse Shoulder System (K213349)Catalyst Orthoscience, Inc.2022-06-23
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K220413)Canary Medical USA, LLC2022-06-22
Klassic Knee System (K211877)Total Joint Orthopedics, Inc.2022-06-22
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System (K220478)Nu Vasive, Incorporated2022-06-21
Baby Gorilla/Gorilla Plating System (K221465)Paragon 28, Inc.2022-06-17
restor3d TiDAL Lumbar Interbody Fusion Device (K220523)Restor3D2022-06-17
TLC Unicompartmental Knee System (K212870)Signature Orthopaedics Pty, Ltd.2022-06-16
DePuy 3D Additive TriFlange Acetabular Cup (K201348)Depuy International, Ltd.2022-06-16
EasyClip® and EasyClip® Xpress (K210582)Stryker GmbH2022-06-10
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System (K220319)Stryker GmbH2022-06-10
iFuse-TORQ® Implant System (K213667)SI-BONE, Inc.2022-06-10
Omni Foot and Ankle Plating System (K221362)Exremity Medical, LLC2022-06-10
KHEIRON® Spinal Fixation System (K211981)S.M.A.I.O2022-06-09
RedPoint Medical's Better Bunion System (K220717)Redpoint Medical, LLC2022-06-09
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (K220782)Alphatec Spine, Inc.2022-06-09
FairFix AM Adjustable Button FairFix PSP Adjustable Button (K221389)Medacta International S.A.2022-06-08
INHANCETM Hybrid Anatomic Glenoid Implant (K212933)Depuy Ireland UC2022-06-08
FX V135 Shoulder Prosthesis (K213117)Fx Shoulder USA, Inc.2022-06-07
Arthrex Knotless AC Repair Devices (K220947)Arthrex, Inc.2022-06-06
Smart Correction System Rings and Compatible HA-Coated Half Pins (K221366)Wishbone Medical, Inc.2022-06-06
Keos Anterior Cervical Interbody Fusion Device System (K212450)Keos2022-06-06
BiMobile Instruments (for BiMobile Dual Mobility System) (K211567)Waldemar Link GmbH & Co. KG2022-06-03
Zavation eZspand Interbody System (K220581)Zavation Medical Products, LLC2022-06-02
Restoris Multi-Compartmental Knee System (K220930)Mako Surgical Corp.2022-06-02
M6-C Artificial Cervical Disc Instruments AS (K220861)Spinal Kinetics, LLC2022-06-02
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