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Orthopedic

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

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RecordFirmDate
4CIS Chiron Spinal Fixation System (K203233)Solco Biomedical Co., Ltd.2022-06-01
TriMed Ripcord Device (K220650)TriMed, Inc.2022-06-01
Bone Cement-Normal Viscosity (K212729)Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda2022-05-31
Navagio Lumbar Cage (K220902)Kalitec Medical, LLC2022-05-27
CoLink PCR Plating System (K213698)In2bones USA, LLC2022-05-27
SOLO-L (K220610)Aurora Spine, Inc.2022-05-27
iFuse Bedrock Granite™ Implant System (K220195)SI-BONE, Inc.2022-05-26
restor3d MTP Implant (K201393)Restor3D, Inc.2022-05-25
CD Horizon™ Spinal System (K221244)Medtronic2022-05-25
BENCOX Mirabo Z Cup Cortinium (K210614)Corentec Co., Ltd.2022-05-24
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (K220888)Medacta International S.A.2022-05-24
M-Vizion Monobloc (K212327)Medacta International S.A.2022-05-24
LigaPASS™ 2.0 Ligament Augmentation System (K213659)Medicrea International SA2022-05-24
CalcShift™ Displacement Calcaneal Osteotomy System (K212979)Nextremity Solutions, Inc.2022-05-20
X-Twist PEEK Suture Anchor (K221135)Parcus Medical, LLC2022-05-19
SMR Reverse Liner (K220792)Lima Corporate S.P.A.2022-05-19
Univers Revers Humeral Cup Implant (K221232)Arthrex, Inc.2022-05-19
PINE Pedicle Screw System (K220285)Tdm Co., Ltd.2022-05-19
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (K211869)Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE2022-05-19
Osteotomy Truss System (OTS) (K220463)4Web Medical, Inc.2022-05-18
BENCOX Mirabo Cup System (K220468)Corentec Co., Ltd.2022-05-18
CERAMENT G (DEN210044)Bonesupport AB2022-05-17
Biocore9 Acetabular Cup System (K212761)Biocore9, LLC2022-05-17
Cervical Spine Truss System Plating Solution (CSTS-PS) (K212527)4Web Medical, Inc.2022-05-17
SternaLock Sternal Closure System (K212782)Biomet Microfixation2022-05-17
ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System (K220115)MiRus, LLC2022-05-13
Argo Knotless SP Anchor (K220757)Conmed Corporation2022-05-13
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid (K213785)Limacorporate2022-05-13
Arthrex Self-Punching PushLock Suture Anchor (K221099)Arthrex, Inc.2022-05-13
Flow-Nail (K221115)Flow-Fx, LLC2022-05-13
Hand Trauma Screw System (K220723)Skeletal Dynamics, Inc.2022-05-12
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System (K220711)SeaSpine Orthopedics Corporation2022-05-10
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K221059)Conformis, Inc.2022-05-10
PISCES-SA Standalone ALIF Interbody System (K213935)Osseus Fusion Systems2022-05-06
WaveForm L System, WaveForm TO System, WaveForm TA System (K213420)SeaSpine Orthopedics Corporation2022-05-04
MyKnee R Pin Positioners (K220705)Medacta International S.A.2022-05-04
LINK Endo-Model EVO Knee System (K220628)Waldemar Link GmbH & Co. KG2022-05-03
Arthrx Fracture Plates (K213837)Arthrex, Inc.2022-05-02
ALPHALOK™ Plating System (K212348)Vilex, LLC2022-05-02
ARx Modular Spinal System (K220341)Life Spine, Inc.2022-05-02
EARP Interbody System (K212477)Nvision Biomedical Technologies, Inc.2022-04-28
DVR® Crosslock Wrist Spanning Plate (131849181) (K220244)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech2022-04-28
G7® Vivacit-E® Freedom® Constrained Liner (K212512)Zimmer, Inc.2022-04-28
ExsoMed INnate NanoTM Lag Screw System (K220892)Exsomed Corp.2022-04-27
M.U.S.T. MINI Posterior Cervical Screws System Extension (K220570)Medacta International S.A.2022-04-26
Legion Inserts with JRNY Lock (K220896)Smith & Nephew, Inc.2022-04-26
RibFix Blu Thoracic Fixation System (K212608)Biomet Microfixation2022-04-22
INHANCE™ Reverse Shoulder System (K212737)Depuy Ireland UC2022-04-21
Infinity™ OCT System and PASS OCT Spinal System (K220810)Medicrea International2022-04-19
Altus Spine Interbody Standalone Fusion System (K211837)Altus Partners, LLC2022-04-19
KYPHON VuE Bone Cement (K220131)Tecres S.P.A.2022-04-18
FootHold System (K220797)Crossroads Extremity Systems, LLC2022-04-15
MagnetOs Flex Matrix (K213959)Kuros Biosciences B.V2022-04-14
Cannulated Compression Device System (K210146)Orthopedic Designs North America, Inc.2022-04-13
Anteralign Spinal System with Titan nanoLOCK Surface Technology (K214010)Medtronic Sofamor Danek USA2022-04-12
Ti3Z Lumbar Interbody System (K212811)Zavation Medical Products, LLC2022-04-12
Amis K Long (K220405)Medacta International S.A.2022-04-12
TRELLIS™ SI Joint Fusion System (K212962)Orthofundamentals, LLC2022-04-11
World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) (K220737)Signature Orthopaedics Pty, Ltd.2022-04-11
MP Reconstruction System (K213675)Waldemar Link GmbH & Co. KG2022-04-11
Bioabsorbable Anchor (K213958)Embody, Inc.2022-04-08
CD Horizon™ Spinal System and PASS LP™ Spinal System (K220724)Medicrea International2022-04-08
Drive Rail System (K220809)OrthoPediatrics Corp.2022-04-08
Corin MetaFix™ Hip Stem (K212069)Corin U.S.A. Limited2022-04-07
DRPx Locking Distal Radius Plate System (K212601)Orthopaedic Implant Company2022-04-05
MediExpand Cervical Expandable VBR System (K212126)Cmf Medicon Surgical, Inc.2022-04-04
Invictus® Spinal Fixation System (K214006)Alphatec Spine, Inc.2022-04-04
EMPOWR Revision Knee (K213793)Encore Medical L.P.2022-04-01
Dakota ALIF System (K213118)Precision Spine, Inc.2022-04-01
Hercules Syndesmosis Implant System (K220260)In2bones USA, LLC2022-03-31
ARx® Spinal System (K220025)Life Spine, Inc.2022-03-31
EL CAPITAN Anterior Lumbar Interbody Fusion System (K214047)Astura Medical2022-03-30
Aggeris™-C (K220182)Clariance2022-03-30
Reliance Cervical IBF System (K202266)Reliance Medical Systems, LLC2022-03-29
OSSIOfiber Suture Anchor (K213415)OSSIO , Ltd.2022-03-28
Toro-L Interbody Fusion System (K213355)Integrity Implants, Inc.2022-03-25
BALTEUM - ONE™ Lumbar Plate System (K213820)Huvexel Co. , Ltd.2022-03-25
X-Pac Expandable Lumbar Cage System (K220655)Expanding Innovations, Inc.2022-03-24
FlareHawk Interbody Fusion System (K220453)Integrity Implants, Inc.2022-03-24
COPAL exchange G hip spacer (K220492)Heraeus Medical GmbH2022-03-23
Medline UNITE IM Fibula Implant (K220511)Medline Industries, LP2022-03-22
StealthFix Intraosseous Fixation System (K220181)Nextremity Solutions, Inc.2022-03-22
AFFINITY Proximal Tibia System (K220199)Techfit Digital Surgery, Inc.2022-03-21
Stable-L Standalone Lumbar Interbody System (K212498)Nexus Spine, LLC2022-03-18
DePuy Synthes Radial Head Replacement System (K213563)DePuy Synthes2022-03-18
EMERGE Anterior Cervical Plate System (K220275)Evolution Spine2022-03-18
AccuFit Lateral 2-Hole Plate (K220324)Precision Spine, Inc.2022-03-16
Peridot Spinal Interbody System (K213980)Gbs Commonwealth Co., Ltd.2022-03-15
Optimotion Implants Porous Metal-Backed Patella (K220049)Optimotion Implants, LLC2022-03-14
2.4mm Distal Radius System (K211324)Auxein Medical Private Limited2022-03-14
Intai Anatomic Locking Plate and Screw System (K201229)Intai Technology Corporation2022-03-11
Pectus Support Bar System (K213712)Biomet Microfixation2022-03-11
Apollo Ankle Fracture Plating System (K213005)Glw Medical, Inc.2022-03-11
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (K213827)Smith & Nephew, Inc.2022-03-11
Minuteman G5 MIS Fusion Plate (K211880)Spinal Simplicity, LLC2022-03-11
Shoulder Innovations Total Shoulder System (K213615)Shoulder Innovations, Inc.2022-03-11
SIGNUS SACRONAIL® Transsacral Stabilization System (K212755)Signus Medizintechnik GmbH2022-03-10
Genesys Spine 3DP Lumbar Interbody System (K220096)Genesys Spine2022-03-09
PathLoc Lumbar Interbody Fusion Cage System (K213441)L&K BIOMED Co., Ltd.2022-03-09
Acetabular Dome Hole Plug (K220376)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-03-09
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