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Orthopedic

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

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RecordFirmDate
SutureLoc™ Implant (K223284)Arthrex, Inc.2023-02-02
EmbedMed (K221943)3D Lifeprints UK , Ltd.2023-02-01
My3D® Personalized Pelvic Reconstruction (K223348)Onkos Surgical, Inc.2023-01-30
Prophecy Preoperative Navigation Alignment System (K222835)Wrightmedicaltechnologyinc2023-01-27
Tibia and Fibula System (K213059)Auxein Medical Private Limited2023-01-27
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (K222056)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-26
Flexible Suturing System with Anchors (FSSA) (K222589)Integrity Orthopaedics, Inc.2023-01-26
Advanced Bone Plate (K221150)Double Medical Technology, Inc.2023-01-25
Medline UNITE® Ankle Fusion Plating System (K222665)Medline Industries, Inc.2023-01-25
CREED™ Cannulated Screws (K223847)Glw, Inc.2023-01-25
OsteoCNX (K223563)Converg Engineering2023-01-25
CD Horizon Spinal System (K223494)Medtronic2023-01-23
OIC Variable Angle Small Fragment Locking Plate System (K223118)Orthopaedic Implant Company2023-01-21
GMK Sphere & GMK SpheriKA Cementless (K223548)Medacta International S.A.2023-01-20
ZESPIN SI Joint Fusion System (K223521)Aegis Spine, Inc.2023-01-20
Triathlon® Hinge Knee System (K223528)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
EL CAPITAN Anterior Lumbar Interbody Fusion (K222554)Astura Medical2023-01-19
SI-Cure Sacroiliac Joint Fusion System (K223819)Alevio, LLC2023-01-18
Uni-FuZe-C Bone Strip (K221726)Zavation Medical Products, LLC2023-01-18
Anatomic Bone Plate (K221088)Double Medical Technology, Inc.2023-01-18
FairFix QT Adjustable Button (K223795)Medacta International S.A.2023-01-17
SignaSure Dual Mobility System (K220495)Signature Orthopaedics Pty, Ltd.2023-01-13
Galileo Vertebral Body Replacement Device (K221542)Bright Spine2023-01-13
PathLoc-TA Expandable Lumbar Cage System (K223474)L&K BIOMED Co., Ltd.2023-01-13
NuVasive Modulus-C Interbody System (K223731)Nuvasive, Inc.2023-01-12
INFINITY OCT System (K223764)Medtronic Sofamor Danek USA, Inc.2023-01-11
NuVasive Reline System (K223181)Nu Vasive, Incorporated2023-01-11
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (K223719)Aegis Spine, Inc.2023-01-11
Metal Cannulated Screw (K221090)Double Medical Technology, Inc.2023-01-10
Haymaker® Screw System (K222799)Orthocircle Spine D.B.A. OC Medical Devices2023-01-10
CoCr Head (K211047)Zimmer GmbH2023-01-10
Bone Cement Genta, Bone Cement HV, Bone Cement LV (K211163)Tecres S.P.A.2023-01-09
VADER® Pedicle System, G21 Cement (K222789)Icotec AG2023-01-09
LumiVy™ Lumbar IBF System (K223412)Vy Spine, LLC2023-01-06
ARTICUL/EZE Ceramic Heads (K222296)Depuy Ireland UC2023-01-06
Cervical Spine Truss System (CSTS) Interbody Fusion Device (K221266)4Web Medical, Inc.2023-01-05
Treace Medical Concepts (TMC) Plating System (K221181)Treace Medical Concepts, Inc.2023-01-05
CONDUIT LLIF Straight Inserters (K223671)Enztec Limited2023-01-05
REMEDY Stemmed Knee Spacer (K223650)Osteoremedies, LLC2023-01-05
U-Motion II Acetabular System-Extension line (K221149)United Orthopedic Corporation2023-01-05
AETOS Shoulder System (K220847)Smith & Nephew, Inc.2023-01-03
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (K221333)Acumed, LLC2022-12-29
StageOne™ Select Hip Cement Spacer Molds (K222760)Biomet, Inc.2022-12-28
Medussa-PL Cage (K223654)Medyssey USA, Inc.2022-12-28
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K223565)L&K BIOMED Co., Ltd.2022-12-23
Episealer Patellofemoral System (K221048)Episurf Medical, Inc.2022-12-23
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm (K221193)OSSIO , Ltd.2022-12-23
iFuse Bedrock Granite® Implant System (K222774)SI-BONE, Inc.2022-12-22
Kodiak C Spinal Implant System (K222806)Met One Technologies, LLC2022-12-22
Tesera-K SC System (K223105)Kyocera Medical Technologies, Inc.2022-12-22
Arthrex FiberTak Suture Anchor (K221396)Arthrex, Inc.2022-12-22
ASTRA Spine System (K223273)Spinecraft, LLC2022-12-22
TriMed Wrist Fixation System 3 (K222637)TriMed, Inc.2022-12-21
Pristine Arthroscopic Visualization System (K223244)Pristine Surgical2022-12-21
Advanced Intramedullary Nail System (K221221)Double Medical Technology, Inc.2022-12-21
Smart SPACE Shoulder Planner and 3D Positioners (K222405)Lima Corporate S.P.A.2022-12-20
Invictus® Bone Cement, Invictus Spinal Fixation System (K221926)Alphatec Spine, Inc.2022-12-20
AEON-C™ Stand Alone System (K223140)Dio Medical, Inc.2022-12-20
Mineral Collagen Composite Bioactive Moldable (K221735)Collagen Matrix, Inc.2022-12-20
SpineJack® Expansion Kit (K223294)Stryker Instruments2022-12-20
Arthrex DualCompression Hindfoot Fusion Nail Implant System (K221031)Arthrex, Inc.2022-12-20
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM (K213653)Solco Biomedical Company India Private Limited2022-12-19
MARVEL™ Growing Rods (K213196)Globus Medical, Inc.2022-12-19
Tornier Pyrocarbon Humeral Head (DEN220012)Tornier S.A.S.2022-12-16
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor (K213110)Auxein Medical Private Limited2022-12-16
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology (K223153)Medtronic Sofamor Danek USA, Inc.2022-12-16
Phantom Metatarsal Shortening System (K223184)Paragon 28, Inc.2022-12-16
Hexanium PLIF (K223251)Spinevision, S.A.S.2022-12-16
BRM TOOL Screws, BIOPLAN Subtalar Implant (K222820)Brm Extremities2022-12-16
REDEMPTION Beaming System (K221342)Vilex, LLC2022-12-13
Hive™ Standalone Cervical System (K223190)NanoHive Medical, LLC2022-12-12
Matrix HA Fusion Porous Cervical IBF System (K223510)Innovasis, Inc.2022-12-12
Metal Bone Screw (K220921)Double Medical Technology, Inc.2022-12-12
MAVERICK Mini External Fixation System (K223112)Smith & Nephew, Inc.2022-12-08
Southern Transforaminal Lumbar Interbody Fusion (TLIF) (K221182)Southern Medical (Pty) , Ltd.2022-12-08
OAKTREE Anterior Lumbar Plate and Screw System (K220843)Oak Tree Engineering, LLC2022-12-07
Femoral Trochanteric Nail System – Neonail (K221021)Neoortho Produtos Ortopédicos S/A2022-12-06
Zavation Spinal System (K222614)Zavation Medical Products, LLC2022-12-05
TruLift Lateral Expandable Spacer System & Lateral Plate System (K221806)Life Spine, Inc.2022-12-05
INHANCETM Shoulder System – Humeral Stems and Stemless (K223211)Depuy Ireland UC2022-12-02
Trigon™ HA Stand-Alone Wedge Fixation System (K223226)Nvision Biomedical Technologies, Inc.2022-12-01
Mercury® II Spinal System (K222516)Spinal Elements, Inc.2022-12-01
Aevumed PHANTOM™-LP Suture Anchors (K222363)Aevumed, Inc.2022-11-28
Momentum® MIS Posterior Spinal Fixation System (K223274)Ulrich Medical USA2022-11-28
Glenoid Reconstruction System (K213459)Medacta International S.A.2022-11-23
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws (K222967)Avanti Orthopaedics, Inc.2022-11-23
BioPoly Lesser Toe Hemiarthroplasty Implant (K222964)BioPoly, LLC2022-11-22
aprevo® anterior lumbar interbody fusion device with interfixation (K222009)Carlsmed, Inc.2022-11-22
ARIX Rib System (K221412)Jeil Medical Corporation2022-11-22
Flex-Thread™ Ulna Intramedullary Nail System (K222390)Flower Orthopedics Corporation Dba Conventus Flower2022-11-21
Treace Medical Concepts (TMC) Implant Fixation System (K222645)Treace Medical Concepts2022-11-21
Tailored-H Cervical Stand Alone System (K222903)Bespoke Technologies, LLC2022-11-18
Opulent TiNbN Coated Knee (K222816)Meril Healthcare Pvt. , Ltd.2022-11-18
Auxilock GFS Mini, GFS II Large, and GFS Ultimate (K213018)Auxein Medical Private Limited2022-11-18
CODA™ Anterior Cervical Plate System (K222493)Pioneer Surgical Technology, Inc.2022-11-18
COSY Cervicothoracic Occipital Rod-Screw System (K220658)Signus Medizintechnik GmbH2022-11-18
Calibrate LTX Interbody System (K222455)Alphatec Spine, Inc.2022-11-18
MAVEN™ Patient-Specific Instrumentation (K223227)Paragon 28, Inc.2022-11-17
Persona Personalized Knee System (K221479)Zimmer, Inc.2022-11-17
IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem (K222973)Alphatec Spine, Inc.2022-11-17
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