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Orthopedic

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

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RecordFirmDate
LINK MobileLink Acetabular Cup System (K222066)Waldemar Link GmbH & Co. KG2023-04-14
Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (K230424)Omnia Medical, LLC2023-04-12
Arthrex Univers Revers Monoblock Stem Size 4/33 (K230366)Arthrex, Inc.2023-04-10
MISHA Knee System (DEN220033)Moximed, Inc.2023-04-10
PRO Plating System, Stryker Trauma Pelvic Set (Matta) (K223772)Stryker GmbH2023-04-07
EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert (K230169)Encore Medical, L.P Dba Enovis2023-04-06
QUANTUM Patient Specific Instrumentation (PSI) System (K230313)In2bones Sas2023-04-06
T-FIX™ 3DSI Joint Fusion System (K230689)Cutting Edge Spine, LLC2023-04-05
BRM Digitalis Spacer (K220142)Brm Extremities Srl2023-04-04
FiberTak Suture Anchor (K230568)Arthrex, Inc.2023-04-01
Axiom PSR System (K223326)Restor3D2023-03-30
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (K221324)Camber Spine Technologies2023-03-30
Medartis APTUS® Ulna Plates (K223853)Medartis AG2023-03-30
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System (K223342)Crossroads Extremity Systems, LLC2023-03-30
Cemented Tibia Baseplate no Taper with JRNY Lock (K230555)Smith & Nephew, Inc.2023-03-30
SiJoin®T3 (K213815)Vgi Medical, Inc.2023-03-29
RemeOs™ Screw LAG Solid (DEN220030)Bioretec, Ltd.2023-03-29
Calibrate LTX Interbody System (K223611)Alphatec Spine, Inc.2023-03-29
KLS Martin Level One Rib Fixation System (K222397)KLS-Martin L.P.2023-03-29
WishBone Medical Plate and Screw System (K230527)Wishbone Medical, Inc.2023-03-29
Tactoset (K223915)Anika Therapeutics, Inc.2023-03-29
KLS Martin Pure Pectus System (K221938)KLS Martin L.P.2023-03-28
SQUALE (K230026)Implanet, S.A.2023-03-28
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K223803)Canary Medical USA, LLC2023-03-24
SpaceFlex Acetabular Cup (K223441)G21, S.R.L.2023-03-23
Fixone All Suture Anchor (K222423)Aju Pharm Co., Ltd.2023-03-23
Swedge™ Pedicle Screw Fixation System (K230482)Spinal Resources, Inc.2023-03-23
RESPONSE 5.5/6.0 Cannulated Screw System (K222105)OrthoPediatrics Corp.2023-03-23
Stativ® Knotted UHMWPE Suture Anchor (K223889)Healthium Medtech Limited2023-03-22
Tigon Medical Gryphon Anchor Line (K220464)Tigon Medical2023-03-22
SPIRA®-C Integrated Fixation System (K223837)Camber Spine Technologies2023-03-22
Tryptik Ti (K230583)Spineart SA2023-03-22
DSM Biomedical Calcium Phosphate Cement (K230054)Dsm Biomedical2023-03-21
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface (K230471)Waldemar Link GmbH & Co. KG2023-03-21
Entasis 3D Dual-Lead Sacroiliac Implant System (K223708)Corelink, LLC2023-03-21
The Integrity Spine Core System (K223043)Integrity Spine2023-03-20
LOQTEQ® VA Elbow Plates 2.7/3.5 System (K230141)Aap Implantate AG2023-03-17
Aevumed RAPID Suture Anchors (K223878)Aevumed, Inc.2023-03-17
Arthrex 3.9 mm SwiveLock Anchor (K230435)Arthrex, Inc.2023-03-17
EMPOWR Stem Extender, 50mm (K230441)Encore Medical, L.P Dba Enovis2023-03-17
DeGen Impulse AM™ System (K223418)Degen Medical2023-03-17
SMR Stemless Anatomic (K221758)Lima Corporate S.P.A.2023-03-17
BENCOX Delta Option Heads (K223828)Corentec Co., Ltd.2023-03-16
Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (K214001)Biomet Manufacturing Corp2023-03-15
Precice Intramedullary Limb Lengthening System (K220234)Nuvasive Specialized Orthopedics, Inc.2023-03-15
Cervical Plate System (K223753)Double Medical Technology, Inc.2023-03-14
Omnia Medical Coupler-C Anterior Cervical Plate (K223321)Omnia Medical, LLC2023-03-13
Arthrex Knotless FiberTak Suture Anchor (K230433)Arthrex, Inc.2023-03-10
ATTUNE® Revision Cones (K230295)Depuy Ireland UC2023-03-10
Uni Knee Resurfacing System (K221292)Overture Resurfacing, Inc.2023-03-10
Huvex Interspinous Fusion System (K223790)Dio Medical Corp.2023-03-09
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets (K221919)Hemodia Sas2023-03-09
Persona™ Personalized Knee System (K230321)Zimmer, Inc.2023-03-08
SINEFIX (K220966)BAAT Medical Products B.V.2023-03-08
Arthrex Virtual Implant Positioning (VIP) System (K222007)Arthrex, Inc.2023-03-08
CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments (K223688)Medos International Sàrl2023-03-08
Tyber Medical Anatomical Plating System (K222465)Tyber Medical, LLC2023-03-07
Athena III Cervical Plate System (K230301)Medyssey USA, Inc.2023-03-07
Pro-X1™ Trochanteric Nailing System (K221621)X-Bolt Orthopedics2023-03-06
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K230315)Materialise NV2023-03-06
Grappler Suture Anchor R3FLEX IOL System (K223589)Paragon 28, Inc.2023-03-03
INJECTION PIN (KIP(02031-02061) (03031-03061)) (K221697)Slk Ortho, LLC2023-03-03
PEEK Spinal Infusion Cage (K223776)Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.2023-03-03
Dyna Locking Trochanteric Nail™ (K221084)Innosys2023-03-03
Magnes-C Anterior Cervical Plate System (K221053)Fellowship of Orthopaedic Researchers, Inc.2023-03-01
U2 Total Knee System-PF+ (K221705)United Orthopedic Corporation2023-02-28
REVCON (TM) Screw System (K223392)Voom Medical Devices, Inc.2023-02-28
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (K230245)L&K BIOMED Co., Ltd.2023-02-28
Ogmend® Implant Enhancement System (K223075)Woven Orthopedic Technologies2023-02-27
BENCOX Mirabo Z Cup Cortinium (K223223)Corentec Co., Ltd.2023-02-27
VySpan™ PCT System (K223852)Vy Spine, LLC2023-02-24
Ti-Largo Cervical Interbody System (K223231)Flospine2023-02-24
MectaLock TI Triple Loaded Suture Anchor (K223582)Medacta International S.A.2023-02-24
OrthoButton AL (K230212)Riverpoint Medical, LLC2023-02-23
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (K213755)Gbs Commonwealth Co., Ltd.2023-02-17
ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device (K222971)Smith & Nephew, Inc.2023-02-17
PROstep(TM) MIS 5mm Chamfer Screw System (K221645)Wright Medical Technology2023-02-17
Bony Trauma Extremity System (BTES) Screw Range, NX Nail (K230118)Field Orthopaedics Pty, Ltd.2023-02-16
JAWS Nitinol Staple System (K223056)Paragon 28, Inc.2023-02-16
Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants (K221468)Acuitive Technologies, Inc.2023-02-14
X-Pac Expandable LLIF Cage System (K223174)Expanding Innovations, Inc.2023-02-14
Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer (K221490)Stryker Spine2023-02-14
Curiteva Porous PEEK Cervical Interbody Fusion System (K213030)Curiteva, Inc.2023-02-13
OIC Intramedullary Screw System (K223761)Orthopaedic Implant Company2023-02-13
EMPOWR™ blade stem (K223779)Encore Medical, LLC2023-02-13
Pisces™-SA STANDALONE ALIF Interbody System (K223413)Osseus Fusion Systems2023-02-10
Orthex External Fixation System (K223786)OrthoPediatrics Corp.2023-02-10
CYGNUS-C Standalone ACIF System (K222041)GS Medical Co., Ltd.2023-02-09
G Surgical Marksman Spinal Deformity System (K230063)G Surgical, LLC2023-02-09
EVOLUTION SPINE Interbody System (K223146)Evolution Spine2023-02-07
Eminent Spine 3D Cervical Interbody Fusion System (K212701)Eminent Spine2023-02-06
Simparo Anchor Line Fixation System (K222574)Simparo, Inc.2023-02-04
COPAL knee moulds (K222570)Heraeus Medical GmbH2023-02-04
GaiaBone Bioabsorbable Bone Graft (K220337)Corliber (Shenzhen) Medical Device Co., Ltd.2023-02-03
Manta Ray TDF Spacer (K220296)SeaSpine Orthopedics Corporation2023-02-03
SMR Shoulder System (K223876)Lima Corporate S.P.A.2023-02-03
MONTAGE Settable, Resorbable Bone Putty (K222063)Orthocon, Inc.2023-02-03
PreView-III™ Anterior Cervical Plate System (K223627)Nexus Spine, LLC2023-02-02
Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (K223362)4Web Medical, Inc.2023-02-02
SmartRelease Endoscopic Soft Tissue Release System (K223406)Microaire Surgical Instruments2023-02-02
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