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Orthopedic

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

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RecordFirmDate
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw (K231819)Innovate Orthopaedics Limited2023-09-05
Montage Flowable Settable, Resorbable Bone Paste (K231270)Orthocon, Inc.2023-09-01
CONDUIT™ ATP Inserters (K232014)Enztec Limited2023-09-01
KITE Distal Fibula Kit (K230623)Intrauma S.P.A2023-09-01
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor (K232340)Arthrex, Inc.2023-09-01
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (K222988)Ht Medical D.B.A. Xenix Medical2023-09-01
TriMed Clavicle Fixation System (K230805)TriMed, Inc.2023-09-01
AlphaVent Suture Anchors (K231093)Stryker Endoscopy2023-08-30
Nexis® compressive screws (K223468)Novastep2023-08-30
StealthFix Intraosseous Fixation System (K232324)Medartis, Inc.2023-08-30
Precice Ankle Salvage System (K230765)Nuvasive Specialized Orthopedics, Inc.2023-08-29
ARROW Off-Centred Humeral Insert (K232226)FH Industrie2023-08-29
Distal Elbow Plating System (K231623)Skeletal Dynamics, Inc.2023-08-28
Treace Medical Concepts (TMC) Compression Implant System (K232387)Treace Medical Concepts2023-08-28
Montage-QS Settable, Resorbable Bone Putty (K231903)Orthocon, Inc.2023-08-25
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors (K230094)Responsive Arthroscopy, LLC2023-08-25
AccelFix Lumbar Expandable Cage System (K231680)L&K BIOMED Co., Ltd.2023-08-24
CATAMARAN SI Joint Fusion System (K231944)Tenon Medical, Inc.2023-08-24
Zenius™ Spinal System (K232218)Medyssey USA, Inc.2023-08-24
Arthrex Radiopaque FiberTape Cerclage sutures (K230976)Arthrex, Inc.2023-08-24
APS Metal Plate & Screw System (K223150)A Plus Biotechnology Co., Ltd.2023-08-24
Zavation Connector System (K231811)Zavation Medical Products, LLC2023-08-22
TITAN 3-D Wedge System (K231496)Paragon 28, Inc.2023-08-22
Cove Strip (K230486)SeaSpine Orthopedics Corporation2023-08-21
Grappler Suture Anchor System (K231867)Paragon 28, Inc.2023-08-21
Stable-C Interbody System (K231763)Nexus Spine, LLC2023-08-21
Pediatric Nailing Platform Tibia (K231266)OrthoPediatrics Corp.2023-08-21
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (K231262)Stryker GmbH2023-08-18
Pangea Utility Plating System, Pangea Platform (K231257)Stryker GmbH2023-08-18
ZSFab Cervical Interbody System (K232150)Zsfab, Inc.2023-08-18
Sterile Products of the APTUS System (K232144)Medartis AG2023-08-18
Tandry Locking Plate System (K230690)Microware Precision Co., Ltd.2023-08-17
Kyphoplasty Balloon Catheter (K223709)Jiangsu Changmei Medtech Co., Ltd.2023-08-16
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) (K232141)Medtronic Sofamor Danek USA, Inc.2023-08-16
primaLOK™ SP Interspinous Fusion System (K231807)Wenzel Spine, Inc.2023-08-15
Xenix Medical Sacroiliac Fixation System (K231829)Ht Medical D.B.A. Xenix Medical2023-08-15
SPICCA Cervical Fusion Cages (K230607)Southern Medical (Pty) , Ltd.2023-08-14
SPICCA Stand-Alone Cervical Fusion Cages (K230608)Southern Medical (Pty) , Ltd.2023-08-14
Electro-Spec Steri-Caps (K231905)Electro-Spec, Inc.2023-08-14
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System (K232311)L&K BIOMED Co., Ltd.2023-08-14
NITINEX Memory Compression Staple (K231493)Vilex, LLC2023-08-11
Medline UNITE® REFLEX® Nitinol Staple System (K231885)Medline Industries, LP2023-08-09
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) (K231376)Smith & Nephew, Inc.2023-08-09
Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (K231114)Zimmer Switzerland Manufacturing GmbH2023-08-09
Arthrex TightRope II (K231857)Arthrex, Inc.2023-08-08
LineSider® Spinal System (K231098)Integrity Implants, Inc.2023-08-07
Titus Titanium Cervical by SAGICO (K221138)Sagico VA USA, LLC2023-08-04
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) (K232005)Smith & Nephew, Inc.2023-08-04
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (K231404)Healthium Medtech Limited2023-08-04
STRETTO™ Cable System (K231333)Globus Medical, Inc.2023-08-04
Extremity Staple (K231458)Restor3D2023-08-03
TiLink-L Joint Fusion System (K231831)Surgentec2023-08-03
NorthStar OCT System (K231654)Seaspine, Inc.2023-08-03
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (K221894)Globus Medical, Inc.2023-08-03
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors (K223114)Gm Dos Reis Industria E Comerico Ltda.2023-08-02
Mineral Collagen Composite Bioactive Extra Moldable (K231942)Collagen Matrix, Inc.2023-08-02
Sapphire X3 Anterior Cervical Plate System (K231593)Spinal Elements, Inc.2023-08-02
Knotless Suture Anchor (K231278)Riverpoint Medical, LLC2023-08-01
SI-Cure Sacroiliac Joint Fusion System (K231951)Alevio, LLC2023-07-28
Adena-Zina Spinal System (K231931)Shanghai Sanyou Medical Co, Ltd.2023-07-28
IBS-B MIS Beveled Screw System (K231236)In2bones USA, LLC2023-07-27
DEPUY SYNTHES MAXFRAME AUTOSTRUT System (K231922)DePuy Synthes2023-07-26
ecoFIX® (K231787)Science & Bio Materials (S.B.M.) Sas2023-07-26
HS Fiber Cerclage (K220765)Riverpoint Medical, LLC2023-07-26
CarboClear Cervical Cage System, CarboClear Cervical VBR System (K222874)Carbofix Orthpedics , Ltd.2023-07-26
Exceed™ Biplanar Expandable Interbody System (K231275)Spine Wave, Inc.2023-07-25
INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516)Depuy Ireland UC2023-07-21
MySpine Unilateral Guides (K231483)Medacta International S.A.2023-07-21
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316)Conformis, Inc.2023-07-21
CastleLoc-S Posterior Cervical Fixation System (K231840)L&K BIOMED Co., Ltd.2023-07-20
INERTIA® CONNEXX™ Modular Pedicle Screw System (K231799)Nexxt Spine, LLC2023-07-20
QUASAR Standalone ACIF System (K231808)GS Medical Co., Ltd.2023-07-20
TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (K231292)Bonebridge AG2023-07-19
TANDEM Hip System (K231448)Smith & Nephew, Inc.2023-07-19
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (K231839)L&K BIOMED Co., Ltd.2023-07-19
Forma Medical Headless Compression Screw (K230945)Forma Medical, Inc.2023-07-18
Arthrex Intramedullary Nails (K230257)Arthrex, Inc.2023-07-17
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System (K230846)Conformis, Inc.2023-07-17
OPTIX H2 Patient Specific Instrument System (K230462)Vilex, LLC2023-07-17
TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (K223252)Exactech, Inc.2023-07-17
ARIX Ankle System (K231441)Jeil Medical Corporation2023-07-17
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System (K231460)K&J Consulting Corp.2023-07-16
PathLoc SI Joint Fusion System (K231841)L&K BIOMED Co., Ltd.2023-07-14
Ruthless Spine RJB (DEN230012)Ruthless, LLC Dba Ruthless Spine2023-07-14
Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (K231438)Alphatec Spine, Inc.2023-07-13
activL® Next Generation Instrumentation (K231769)Aesculap Implants Systems, LLC2023-07-13
NanoHive Medical Lumbar Interbody System (K231241)NanoHive Medical, LLC2023-07-12
Graftys Quickset (K231714)Graftys2023-07-12
Comprehensive Segmental Revision System(SRS) (K223631)Biomet Orthopedics2023-07-12
Bonalive Orthopedics granules (K231528)Bonalive Biomaterials, Ltd.2023-07-11
SPIRA® Posterior Lumbar Spacers (K230942)Camber Spine Technologies2023-07-11
MINIMA S System (K231925)Lima Corporate S.P.A.2023-07-11
NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System (K231735)Nu Vasive, Incorporated2023-07-11
Edge Upper Cervical System (K221307)Spinal Simplicity, LLC2023-07-10
Overture Orthopaedics Patellofemoral System (K231253)Overture Resurfacing, Inc.2023-07-07
ProMIS™ Fixation System (K231844)Premia Spine, Ltd.2023-07-07
VERTICALE® Triangular Fixation System (K223806)Silony Medical GmbH2023-07-06
Tyber Medical Pin and Wire System (various) (K231339)Tyber Medical, LLC2023-07-06
Rotium Bioresorbable Wick (K231641)Nanofiber Solutions, LLC2023-07-05
Integral Titanium Cervical Interbody (K222015)Nvision Biomedical Technologies, Inc.2023-07-05
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