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Orthopedic

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

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RecordFirmDate
Life Spine ALIF Buttress Plate System (K222628)Life Spine, Inc.2022-11-16
Dyflex-II (K212700)Taeyeon Medical Co., Ltd.2022-11-15
Omnia Medical TiBrid-SC (K212612)Omnia Medical, LLC2022-11-15
Treace Medical Concepts (TMC) Hammertoe Fixation System (K222564)Treace Medical Concepts, Inc.2022-11-15
ALPHALOK Plating System (K221558)Vilex, LLC2022-11-15
Gamma4 System (K222309)Stryker GmbH2022-11-15
HBL Blade Assembly (K222490)Hand Biomechanics Lab, Inc.2022-11-14
Smith & Nephew Intramedullary Nail Systems (K210980)Smith & Nephew, Inc.2022-11-14
Hexanium ACIF (K221578)Spinevision, S.A.S.2022-11-14
Catalyst EA Convertible Stemmed Shoulder (K222317)Catalyst Orthoscience, Inc.2022-11-10
MONET Anterior Cervical Plate System (K220334)Ctl Medical Corporation2022-11-09
WaveForm A Interbody System (K222732)SeaSpine Orthopedics Corporation2022-11-07
Humeris® 135 Shoulder System (K222936)Fx Shoulder USA, Inc.2022-11-07
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL (K220833)Acuitive Technologies, Inc.2022-11-04
Humerus & Ulna System (K213108)Auxein Medical Private Limited2022-11-04
World Total Knee System (K223062)Signature Orthopaedics Pty, Ltd.2022-11-04
United U2 femoral head, 22mm delta ceramic head (K221675)United Orthopedic Corporation2022-11-04
Nextra CH Cannulated Hammertoe System (K221610)Nextremity Solutions, Inc.2022-11-04
UniVy OsteoVy Cervical IBF System (K221162)Vy Spine, LLC2022-11-04
ABTross ALIF Expandable Cage System (K221719)Aegis Spine, Inc.2022-11-03
Black Diamond™ POCT Spinal System (K222107)Osseus Fusion Systems2022-11-03
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System (K222653)Smith+Nephew, Inc.2022-10-28
Spinal Inner Fixation System (K222031)Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.2022-10-28
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System (K222282)Hospital Equipment Manufacturing Company2022-10-27
Artemis Proximal Femoral Nail System (K221489)Glw, Inc.2022-10-27
CurvaFix IM System (K222505)Curvafix, Inc.2022-10-27
FIREFLY® Cervical Navigation Guide (K220132)Mighty Oak Medical, Inc.2022-10-26
TEMA Elbow system - Line extension (K222807)Lima Corporate S.P.A.2022-10-26
Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices (K223065)Adcura, Inc.2022-10-26
Rexious Spinal Fixation System (K222415)Dio Medical Corporation2022-10-25
MectaLIF Anterior Extension (K221545)Medacta International S.A.2022-10-24
The GIRO Growth Modulation System (K220190)Pega Medical, Inc.2022-10-24
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (K222270)Globus Medical, Inc.2022-10-21
NuVasive Cohere ALIF System Intervertebral Body Fusion Device (K221751)Nu Vasive, Incorporated2022-10-21
UHR Bipolar Implants, Restoration GAP II Implants (K222632)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-10-21
DePuy Reclaim Monobloc Revision Femoral Stem (K221462)Depuy Ireland UC2022-10-21
Tyber Medical Staple Fixation System (various) (K221947)Tyber Medical, LLC2022-10-20
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate (K221728)Stryker Corporation2022-10-19
STERN FIX Sternal Stabilization System (K221795)Neos Surgery S.L2022-10-19
EVOS Wrist Spanning Plate (K213123)Smith & Nephew, Inc.2022-10-18
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System (K222572)Dio Medical Corporation2022-10-18
DualXSLIM(R) T/PLIF (K222203)Amplify Surgical, Inc.2022-10-18
TELIGEN System (K213978)Medos International SARL2022-10-18
Standalone ALIF Interbody Fusion System (K221936)Eminent Spine2022-10-17
Zimmer Persona Personalized Knee System (K222566)Zimmer, Inc.2022-10-17
ATTUNE Revision Cones (K212746)Depuy Ireland UC2022-10-17
CASSATT™ SIJ Fixation System (K211785)Ctl Medical Corporation2022-10-17
CONDUIT Cages; FIBERGRAFT BG Putty (K222276)Depuy Spine2022-10-15
Southern Anterior Screw Fixated Cage (SASCA) (K221447)Southern Medical (Pty) , Ltd.2022-10-14
Tornier Perform Humeral System – Fracture (K220914)Tornier, Inc.2022-10-14
X-Pac Expandable Lumbar Cage System (K222797)Expanding Innovations, Inc.2022-10-14
FOCUS Interbody System (K221172)Oc Medical Devices2022-10-14
ZSFab Lumbar Interbody System (K221858)Zsfab, Inc.2022-10-14
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods (K222473)Medos-International Sarl2022-10-13
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors (K222763)Responsive Arthroscopy, LLC2022-10-13
UNITY Sacroiliac Joint Fixation System (K222448)Dio Medical Corporation2022-10-13
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 (K222028)Alphatec Spine2022-10-07
Tibial baseplate, Tibial insert (K222700)United Orthopedic Corporation2022-10-06
b-ONER MOBIO Total Knee System (K222431)B-One Ortho, Corp.2022-10-06
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (K211892)Arftx Medical, LLC2022-10-06
PRIMA TT Glenoid (K222427)Lima Corporate S.P.A.2022-10-06
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II (K221128)Arthrex, Inc.2022-10-05
CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (K221646)Medtronic Sofamor Danek USA, Inc.2022-10-04
TriVerse Total Knee Replacement System (K222380)Signature Orthopaedics Pty, Ltd.2022-10-04
SILO TFX MIS Sacroiliac Joint Fixation System (K221047)Aurora Spine, Inc.2022-10-03
ONVOY Acetabular System (K213842)Globus Medical, Inc.2022-10-03
Varixis Elbow System (K213014)Auxein Medical Private Limited2022-10-03
Arthrex 2.4 mm Volar Distal Radius Plate System (K222267)Arthrex, Inc.2022-10-03
Arthrex 3.5 mm Locking Compression Plates (K222244)Arthrex, Inc.2022-09-30
Mg-PSZ Ceramic Femoral Head (K220336)Theken Companies2022-09-30
iFuse TORQ® Implant System (K222605)SI-BONE, Inc.2022-09-29
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (K213126)Smith & Nephew, Inc.2022-09-29
Ghost Spacer System (K213417)Life Spine, Inc.2022-09-29
AGILON XO Shoulder System (K222482)Implantcast GmbH2022-09-28
Medline UNITE® Medial Malleolus Peg Plate System (K221360)Medline Industries, LP2022-09-27
Platform® Acetabular System (K220483)Total Joint Orthopedics, Inc.2022-09-23
Align (K222561)Acuity Surgical Devices, LLC2022-09-23
WasherCap Fixation System (K212197)Abanza Tecnomed S.L2022-09-22
DePuy Synthes 3.5mm Intrapelvic Acetabular System (K221809)DePuy Synthes2022-09-20
Tandry Compression Screw System (K220359)Microware Precision Co., Ltd.2022-09-20
Arthrex Compression FT Pins (K220839)Arthrex, Inc.2022-09-19
Altus Spine Pedicle Screw System (K211027)Altus Partners, LLC2022-09-16
True Tulip, True M.I.S. (K220297)Innovative Surgical Designs, Inc.2022-09-16
CYGNUS™ MoRe Anterior Cervical Plate System (K220441)MiRus, LLC2022-09-16
StageOne™ Shoulder Cement Spacer Molds (K221968)Biomet, Inc.2022-09-15
Identity Shoulder System (K213856)Zimmer, Inc.2022-09-15
MONDRIAN ALIF Cage with Supplementary Fixation Plate (K213641)Ctl Medical Corporation2022-09-15
Tornier Perform Humeral System – Stemless (K220418)Tornier, Inc.2022-09-14
Grappler Suture Anchor System (K222091)Paragon 28, Inc.2022-09-14
SP-CL Hip Stem and LCU Hip System (K213770)Waldemar Link GmbH & Co. KG2022-09-13
ChoiceSpine TigerShark™ M, Modular Interbody System (K220953)Choice Spine, LLC2022-09-13
Integrity-SI Fusion System (K222512)OsteoCentric Technologies2022-09-12
NuVasive Reline Cervical System (K221388)Nu Vasive, Incorporated2022-09-09
AUTOBAHN(R) EVO Femoral Nails (K220659)Globus Medical, Inc.2022-09-09
CAPTIVATE® Compression Screws (K222409)Globus Medical, Inc.2022-09-08
Mariner RDX System (K222110)SeaSpine Orthopedics Corporation2022-09-07
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (K221731)T.A.G. Medical Products Corporation, Ltd.2022-09-07
EMPHASYS Acetabular System (K221636)Depuy Ireland UC2022-09-06
Hammertoe Truss System (HTS) (K221283)4Web Medical, Inc.2022-09-06
Camber Sacroiliac (SI) Fixation System (K203503)Camber Spine Technologies, LLC2022-09-02
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