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HRS

1,320 FDA 510(k) clearances · Product code

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RecordFirmDate
AxSOS 3 AF System and AxSOS 3 Ti System (K200398)Stryker GmbH2020-06-05
Skeletal Dynamics Forearm Plating System (K200538)Skeletal Dynamics, Inc.2020-06-01
JPS JuniOrtho Plating System (K200246)Orthofix Srl2020-05-22
Skeletal Dynamics Midshaft Humerus Plating System (K200701)Skeletal Dynamics, Inc.2020-05-14
Distal Humerus Plating System (K200367)Skeletal Dynamics, Inc.2020-05-14
Treace Medical Concepts (TMC) Plating System (K200961)Treace Medical Concepts, Inc.2020-05-08
CoLink Cfx Plating System (K200762)In2bones USA, LLC2020-04-23
ATLAS Plating System (K191867)MiRus, LLC2020-04-09
GEO 1st MTP Joint Arthrodesis Plating System (K200108)Gramercy Extremity Orthopedics, LLC2020-03-26
APTUS® Ankle Trauma System 2.8/3.5 (K193633)Medartis AG2020-03-26
APTUS® Foot 2.8-3.5 System (K193639)Medartis AG2020-03-26
FINE Osteotomy around the knee (K193614)Bodycad Laboratories, Inc.2020-03-25
Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (K200043)Field Orthopaedics Pty, Ltd.2020-03-23
Park's Pectus System (K191057)Tdm Co., Ltd.2020-03-19
ARIX Ankle System (K193616)Jeil Medical Corporation2020-03-04
Pitkar Locked Plating System (K192619)S.H.Pitkar Orthotools Pvt. , Ltd.2020-02-27
APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System (K193554)Medartis AG2020-02-16
Comus Locking Plate systems (K190842)Jiangsu Trauhui Medical Instrument Co., Ltd.2020-02-03
APTUS Clavicle System (K192984)Medartis AG2020-01-24
Tyber Medical Anatomical Plating System (K193222)Tyber Medical, LLC2020-01-20
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System (K193543)In2bones USA, LLC2020-01-17
MotoBAND CP Implant System (K193452)Crossroads Extemity Systems, LLC2020-01-10
TriMed ASET Foot Plating System (K192696)TriMed, Inc.2020-01-05
Mini and Micro Fragments Reconstruction System – GMReis (K182718)Gm Dos Reis Industria E Comerico Ltda.2019-12-23
Airlock Centrolock Osteosynthesis Implant System (K192356)Novastep2019-12-14
Avanti Distal Radius and Forearm System (K191118)Avanti Orthopaedics, Inc.2019-12-13
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System (K191793)Nebula Surgical Private Limited2019-12-09
Exsomed Wrist Plating System (K192473)Exsomed Corporation2019-12-03
VariAx Foot (K192675)Stryker GmbH2019-11-22
Axis Plating System (K192592)Extremity Medical, LLC2019-11-21
PolyLock Small Bone Plating System (K192323)Fusion Orthopedics, LLC2019-11-18
TDM Plate and Screw Systems (K190391)Tdm Co., Ltd.2019-11-15
ARIX Wrist System (K191972)Jeil Medical Corporation2019-11-12
APTUS Wrist Arthrodesis Plates (K192297)Medartis AG2019-11-08
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile (K192327)Synthes (USA) Products, LLC2019-11-07
Treace Medical Concepts (TMC) Plating System (K192504)Treace Medical Concepts, Inc.2019-10-30
Arthrex Minimally Invasive Ankle Fusion Plate (K190953)Arthrex, Inc.2019-10-16
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module (K191326)Arthrex, Inc.2019-10-15
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module (K191344)Arthrex, Inc.2019-10-03
APTUS Wrist Spanning Plates 2.5 (K191848)Medartis AG2019-09-30
AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (K191641)Industrias Medicas Sampedro S.A.S2019-09-16
NCB Plating System Distal Femur and Proximal Tibia (K192217)Zimmer GmbH2019-09-13
VariAx 2 System, VariAx 2 Mini Fragment System (K191412)Stryker GmbH2019-08-23
NCB Polyaxial Locking Plate System (K192021)Zimmer GmbH2019-08-22
Arsenal Plating System (K191009)Trilliant Surgical2019-08-12
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (K190385)In2bones USA, LLC2019-08-08
OrthoPediatrics PediFoot Deformity Corrections System (K190992)OrthoPediatrics Corp.2019-08-06
LOQTEQ VA Calcaneus Plate 3.5 (K182818)Aap Implantate AG2019-08-01
CoLink® Mini Plating System (K191535)In2bones USA, LLC2019-07-29
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional (K190963)Synthes (USA) Products, LLC2019-07-23
ORTHOLOC™ SPS Shoulder Plating System (K191711)Tornier, Inc.2019-07-17
DePuy Synthes Plates and Screws Portfolio (K190750)DePuy Synthes2019-06-21
LOQTEQ VA Foot Plates 2.5 (K182785)Aap Implantate AG2019-06-19
Arzzt Distal Radius and Ulna System (K182650)Truemed Group, LLC2019-06-10
RIVAL View Plating Systems and Reduce Fracture Plating Systems (K190388)Orthofix Srl2019-06-07
PROSTEP TBC Implant System (K183620)Wrightmedicaltechnologyinc2019-06-06
ORTHOLOC™ 2 Lapidus with Rotation System (K190670)Wrightmedicaltechnologyinc2019-05-14
MatrixRIB Fixation System (K190409)DePuy Synthes2019-05-03
ATLAS Plating System (K190415)MiRus, LLC2019-04-19
Baby Gorilla/Gorilla Plating System (K190365)Paragon 28, Inc.2019-04-12
MIS Bunion Plating System (K190658)Crossroads Extremity Systems, LLC2019-04-12
EVOS Small Fragment Upper Extremity Plates Line Additions (K190253)Smith & Nephew, Inc.2019-03-11
Stryker SternalPlate System (K183172)Stryker2019-03-05
MLP Special Locking Bone Plate System (K181843)Maxxion Medical, LLC / Baumer SA2019-03-04
MIS Bunion System (K181872)Crossroads Extremity Systems, LLC2019-02-19
AdvantageRib System (K183317)Sig Medical Corporation2019-02-14
EPIC Extremity Fusion Plate System (K182991)Epic Extremity, LLC2019-02-13
Treace Medical Concepts (TMC) Plating System (K183321)Treace Medical Concepts, Inc.2019-01-25
Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (K183011)Additive Orthopaedics2019-01-10
DePuy Synthes Trauma Orthopedic Nail Implants (K182783)DePuy Synthes2018-12-26
TruMatch Graft Cage - Long Bone (K180821)Synthes (Usa), LLC2018-12-21
Distal Radius Plating System (K182810)Miami Device Solutions, LLC2018-12-10
ARIX Sternal System (K181806)Jeil Medical Corporation2018-11-20
AdvantageRib Anterior System (K182179)Sig Medical Corp.2018-11-16
Stratum™ Foot Plating System (K182201)Nextremity Solutions, Inc.2018-11-16
Medline Unite Mini Plates and Screws (K181820)Medline Industries, Inc.2018-11-01
DePuy Synthes Trauma Orthopedic Plates and Screws (K180310)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2018-11-01
AOS Calcaneal Plating System (K182466)Advanced Orthopaedic Solutions2018-10-30
ANTHEM Fracture System (K180554)Globus Medical, Inc.2018-10-22
Titanium TomoFix Medial High Tibia Plate Anatomical (K180213)Synthes (USA) Products, LLC2018-10-19
Piccolo Composite® Plate System (K182015)CarboFix Orthopedics , Ltd.2018-10-11
AxSOS 3 Ti (K181091)Stryker GmbH2018-10-11
Geminus Volar Distal Radius Plate System (K182492)Skeletal Dynamics, LLC2018-10-10
ORTHOLOC SPS Shoulder Plating System (K181587)Tornier, Inc.2018-10-05
WishBone Medical Plate and Screw System (K180736)Wishbone Medical, Inc.2018-10-04
ARIX Clavicle System (K180972)Jeil Medical Corporation2018-10-03
CoLink View Plating System (K182402)In2bones USA, LLC2018-09-27
Tandry Locking Plate System (K171904)Microware Precision Co., Ltd.2018-09-18
APTUS CMC-I Fusion Plate System (K181009)Medartis AG2018-08-24
AOS Small Fragment Plating System Lite (K181035)Advanced Orthopaedic Solutions, Inc. (Aos)2018-08-24
EVOS Wrist Fracture Plating System (K181533)Smith & Nephew, Inc.2018-08-09
APTUS® Proximal Humerus System (K181425)Medartis AG2018-08-05
PL8 Wrist Reconstruction Plate (K180150)Citieffe S.R.L.2018-08-02
CoLink™ Afx Plating System (K181113)In2bones USA, LLC2018-06-15
AlignX Ankle Fusion System (K181067)Extremity Medical, LLC2018-05-23
Omni Foot Plating System (K180808)Extremity Medical, LLC2018-05-22
Additive Orthopaedics Patient Specific 3D Printed Bone Segments (K180239)Additive Orthopaedics, LLC2018-05-16
Trident Extremity Fixation System (K171690)Trident Orthopedics2018-05-08
A. L. P. S. Clavicle Plating System (K173767)Biomet, Inc.2018-04-06
IXOS Radius Plate System (K171624)Stuckenbrock Medizintechnik GmbH2018-03-29
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