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HRS

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

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RecordFirmDate
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (K210935)I.T.S. GmbH2022-08-31
ARIX Small Fragment System (K221920)Jeil Medical Corporation2022-08-24
Baby Gorilla®/Gorilla® Plating System (K222194)Paragon 28, Inc.2022-08-19
Stryker VariAx 2 MIS Calcaneus (K221346)Stryker GmbH2022-07-08
Footmotion Plating System (K221395)Newclip Technics2022-07-01
Arthrex Mini Fragment System (K220937)Arthrex, Inc.2022-06-29
Baby Gorilla/Gorilla Plating System (K221465)Paragon 28, Inc.2022-06-17
Omni Foot and Ankle Plating System (K221362)Exremity Medical, LLC2022-06-10
CoLink PCR Plating System (K213698)In2bones USA, LLC2022-05-27
CalcShift™ Displacement Calcaneal Osteotomy System (K212979)Nextremity Solutions, Inc.2022-05-20
Osteotomy Truss System (OTS) (K220463)4Web Medical, Inc.2022-05-18
SternaLock Sternal Closure System (K212782)Biomet Microfixation2022-05-17
Arthrx Fracture Plates (K213837)Arthrex, Inc.2022-05-02
ALPHALOK™ Plating System (K212348)Vilex, LLC2022-05-02
DVR® Crosslock Wrist Spanning Plate (131849181) (K220244)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech2022-04-28
RibFix Blu Thoracic Fixation System (K212608)Biomet Microfixation2022-04-22
DRPx Locking Distal Radius Plate System (K212601)Orthopaedic Implant Company2022-04-05
AFFINITY Proximal Tibia System (K220199)Techfit Digital Surgery, Inc.2022-03-21
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
PolyLock Plating System (K211843)Fusion Orthopedics2022-03-04
Medline UNITE Calcaneal Fracture Plating System (K213567)Medline Industries, LP2022-03-02
Arsenal Ankle Plating System (K212378)Trilliant Surgical2022-02-23
Traufix osteosynthesis, osteotomy, and arthrodesis devices (K201510)Fixier S.A. DE C.V.2022-02-18
Treace Medical Concepts (TMC) Plating System (K220136)Treace Medical Concepts, Inc.2022-02-16
FlexitSystem Knee osteotomy system (K212545)Neosteo2022-02-11
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate (K213489)Wishbone Medical, Inc.2022-01-27
ANTHEM® Fracture System (K213591)Globus Medical, Inc.2022-01-26
SternaFuse Fixation System (K202914)Fusion Innovations, LLC2022-01-26
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (K212581)Stryker GmbH2022-01-19
Distal Humerus Plating System (K213895)Skeletal Dynamics, Inc.2022-01-13
GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive (K210198)Gpc Medical Limited2022-01-07
Pectus Blu Support Bar System (K212841)Biomet Micofixation2022-01-07
Activmotion S DTO (K202803)Newclip Technics2021-12-16
CoLink NeoFuse Plating System (K213069)In2bones USA, LLC2021-12-13
Xpert Wrist (K213214)Newclip Technics2021-11-24
The Radian MIS Bunion System (K211650)Nvision Biomedical Technologies, Inc.2021-11-24
CoLink Vallux Plating System (K212487)In2bones USA, LLC2021-11-18
Stratum® Ankle Fusion Plating System (K212640)Nextremity Solutions, Inc.2021-11-18
LOQTEQ Proximal Humerus Plate 3.5 System (K211582)Aap Implantate AG2021-10-18
SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System (K203002)Bonebridge AG2021-10-05
Anthem Fracture System (K212433)Globus Medical, Inc.2021-10-01
GEO Extremity and Ankle Plating System (K212334)Gramercy Extremity Orthopedics, LLC2021-09-21
Omni Foot and Ankle Plating System (K212297)Extremity Medical, LLC2021-08-20
Tyber Medical Anatomical Plating System (K203817)Tyber Medical, LLC2021-08-13
Summit Patella Plating System (K203408)Endeavor Orthopaedics, LLC2021-07-30
FINE Osteotomy (K211646)Bodycad Laboratories, Inc.2021-07-28
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (K210016)Integra LifeSciences Corporation2021-07-27
Avanti Orthopaedics Ulnar Shortening System (K211592)Avanti Orthopaedics, Inc.2021-07-16
Acumed Clavicle Hook Plating System (K210750)Acumed, LLC2021-07-15
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM (K200575)Truemed Group, LLC2021-07-09
Smith & Nephew Plates and Screws (K210837)Smith & Nephew, Inc.2021-06-29
Valkyrie Thoracic Fixation System (K211695)Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices2021-06-23
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) (K211051)DePuy Synthes2021-06-02
DRPx Locking Distal Radius Plate System (K202971)Orthopaedic Implant Company2021-05-06
JACE Medical Thoracic Plating System (K210290)Jace Medical, LLC2021-04-30
SOLE Medial Column Fusion Plate (K210157)Orthofix Srl2021-04-20
Volition Plating System (K210658)Ortho Solutions UK , Ltd.2021-04-13
DePuy Synthes Variable Angle Locking Patella Plating System (K210408)Synthes (USA) Products, LLC2021-04-08
GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System (K210534)Gramercy Extremity Orthopedics, LLC2021-03-26
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System (K210205)Synthes (USA) Products, LLC2021-03-26
Arthrex Patella SuturePlates (K203834)Arthrex, Inc.2021-03-25
CoLink Mfx Implant System (K210060)In2bones USA, LLC2021-03-12
Versalock Periprosthetic Femur Plates System-GMReis (K201728)GM Dos Reis Industria e Comercio Ltda.2021-03-08
LOQTEQ Distal Lateral Femur Plate 4.5 System (K210043)Aap Implantate AG2021-03-03
Able Medical Devices Valkyrie Thoracic Fixation System (K202889)Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021-03-02
ExtremiLOCK Lateral Ankle Fusion Plates (K203479)Osteomed2021-02-24
Foot and Ankle System (K200062)Leith Medical, LLC2021-02-22
A.L.P.S. Clavicle Plating System (K210192)Biomet, Inc.2021-02-19
Arthrex Pilon Fusion System (K203294)Arthrex, Inc.2021-02-03
Biomet Microfixation RibFix Advantage System (K203474)Biomet Micofixation2021-01-28
EVOS Large Fragment Plating System (K203405)Smith & Nephew, Inc.2021-01-27
ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System (K201259)Wrightmedicaltechnologyinc2021-01-08
Baby Gorilla/Gorilla Plating System (K203511)Paragon 28, Inc.2020-12-29
DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K203414)DePuy Synthes2020-12-16
Javelin Tailor's Bunion Fixation System (K202657)Nvision Biomedical Technologies, Inc.2020-12-14
PolyLock Plating System (K202959)Fusion Orthopedics, LLC2020-11-24
Ortho Solutions Plating System (K202764)Ortho Solutions UK , Ltd.2020-11-20
Activ Fuse (K202307)Newclip Technics2020-11-17
EVOS Large Fragment Plating System (K201918)Smith & Nephew, Inc.2020-11-16
ANTHEM Fracture System (K202496)Globus Medical, Inc.2020-10-29
ARIX Ankle Distal Tibia System (K202912)Jeil Medical Corporation2020-10-29
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (K202489)Advanced Orthopaedic Solutions, Inc.2020-10-26
Skeletal Dynamics Ulnar Shortening Plating System (K201962)Skeletal Dynamics, Inc.2020-10-13
Piccolo Composite Proximal Tibia Plate System (K201917)CarboFix Orthopedics , Ltd.2020-10-08
ARIX Elbow System (K201656)Jeil Medical Corporation2020-09-15
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K201959)DePuy Synthes2020-09-11
DePuy Synthes Variable Angle Locking Patella Plating System (K201578)Synthes (USA) Products, LLC2020-09-09
Arthrex Mesh Plates (K201677)Arthrex, Inc.2020-09-02
Arthrex Compression Screws (K201132)Arthrex, Inc.2020-07-27
Stratum™ Reduced Size Foot Plating System (K200785)Nextremity Solutions, Inc.2020-07-27
DePuy Synthes 2.7mm VA LCP Clavicle Plate System (K201321)DePuy Synthes2020-07-24
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) (K201527)Smith & Nephew, Inc.2020-07-22
DAC Dynamic Active Compression Plate (K200513)Pioneer Surgical Technology, Inc., Dba Rti Surgical2020-07-22
CoLink Plating System (K201149)In2bones USA, LLC2020-07-15
Arthrex DynaNite Compression Plate (K193345)Arthrex, Inc.2020-07-08
Arthrex MaxForce MTP Compression Plates and Screws (K201235)Arthrex, Inc.2020-07-06
Lever Action Plate System (K200834)Mcginley Orthpaedic Innovations, LLC2020-06-25
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