Orthopedic

HRS · Plate, Fixation, Bone

Orthopedic · 21 CFR 888.3030 · Class 2

Overview

Product CodeHRS
Device NamePlate, Fixation, Bone
Regulation21 CFR 888.3030
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Cleared Devices (1303)

RecordDevice NameApplicantDecision DateDecision
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.Apr 10, 2026SESE
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.Apr 1, 2026SESE
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.Mar 25, 2026SESE
K260274Airlock® Ankle Plating SystemNovastep SASMar 25, 2026SESE
K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AGMar 24, 2026SESE
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.Mar 23, 2026SESE
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.Mar 19, 2026SESE
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.Mar 17, 2026SESE
K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.Mar 17, 2026SESE
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AGMar 16, 2026SESE
K253906Xpert HandNewclip TechnicsMar 11, 2026SESE
K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbHMar 9, 2026SESE
K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.Mar 3, 2026SESE
K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbHMar 2, 2026SESE
K254249HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd.Feb 27, 2026SESE
K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.Feb 26, 2026SESE
K254162KLS Martin Ixos SystemKLS Martin L.P.Feb 20, 2026SESE
K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.Feb 20, 2026SESE
K251732Wrist Fracture SystemMet One Technologies, LLCFeb 12, 2026SESE
K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.Jan 21, 2026SESE
K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)TriMed, Inc.Jan 15, 2026SESE
K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.Jan 12, 2026SESE
K253178TRILEAP Plating SystemCrossroads Extremity SystemsJan 6, 2026SESE
K251050Pectus Versa SystemGm Dos Reis Industria E ComercioDec 19, 2025SESE
K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AGDec 17, 2025SESE
K252997HyperFlex® Bunion Correction SystemHyperflex MedicalDec 11, 2025SESE
K252897APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / DistaA Plus Biotechnology Co., Ltd.Dec 11, 2025SESE
K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.Dec 11, 2025SESE
K252661SternaFuse Ti Fixation SystemFusion Innovations, LLCNov 19, 2025SESE
K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.Nov 18, 2025SESE
K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.Nov 14, 2025SESE
K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc.Nov 13, 2025SESE
K252959WRISTAR MultiAx Distal Radius KitIntrauma S.P.ANov 12, 2025SESE
K253300Fine Osteotomy™Bodycad Laboratories, Inc.Oct 28, 2025SESE
K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.Oct 9, 2025SESE
K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbHSep 8, 2025SESE
K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLCAug 21, 2025SESE
K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical ConceptsAug 21, 2025SESE
K250923Fine Osteotomy™Bodycad Laboratories, Inc.Aug 21, 2025SESE
K252061Distal Xtremities SystemTriMed, Inc.Aug 20, 2025SESE
K251161ANTHEM® Fracture SystemGlobus Medical, Inc.Aug 18, 2025SESE
K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric TechnologiesAug 16, 2025SESE
K250620KLS Martin Ixos SystemKLS Martin L.P.Aug 15, 2025SESE
K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLCJul 30, 2025SESE
K251620A.L.P.S. Proximal Humerus Plating SystemZimmer BiometJul 25, 2025SESE
K250952Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.Jul 18, 2025SESE
K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLCJul 14, 2025SESE
K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.Jul 10, 2025SESE
K242988Genostis Osteosynthesis SystemGenostis AFJun 27, 2025SESE
K250929TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)TriMed, Inc.Jun 26, 2025SESE
K243275Equinoxe® Scapula Fracture SystemExactech, Inc.Jun 26, 2025SESE
K251296The Acumed Wrist Fixation SystemAcumed, LLCJun 18, 2025SESE
K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AGJun 11, 2025SESE
K243368Montblanc Plate SystemMedifield Medical Co., Ltd.Jun 4, 2025SESE
K242751ARIX Pectus Bar SystemJeil Medical CorporationMay 30, 2025SESE
K243469SIGNEXOsteonic Co., Ltd.May 29, 2025SESE
K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)TriMed, Inc.May 22, 2025SESE
K243963Pediatric Plating Platform HipOrthoPediatrics Corp.Apr 29, 2025SESE
K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.Apr 25, 2025SESE
K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.Apr 24, 2025SESE
K250155Xpert KneeNewclip TechnicsApr 23, 2025SESE
K250948TriMed Fusion Cup SystemTriMed, Inc.Apr 8, 2025SESE
K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.Mar 26, 2025SESE
K243999TriMed Ankle Fixation SystemTriMed, Inc.Mar 19, 2025SESE
K243987TriMed Elbow and Forearm SystemTriMed, Inc.Mar 19, 2025SESE
K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLCMar 19, 2025SESE
K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric TechnologiesMar 18, 2025SESE
K250498BPS Wrist Fracture SystemOrthonovis, Inc.Mar 17, 2025SESE
K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AGMar 7, 2025SESE
K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.Feb 27, 2025SESE
K243761A.L.P.S. Small Fragment Plating SystemBiomet OrthopedicsFeb 19, 2025SESE
K241666EVOS Pelvic and Acetabular SystemSmith & NephewFeb 19, 2025SESE
K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.Feb 10, 2025SESE
K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.Feb 6, 2025SESE
K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty , Ltd.Feb 6, 2025SESE
K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.Jan 29, 2025SESE
K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);TriMed, Inc.Jan 15, 2025SESE
K242939ARTFX Trauma Bone Plate and Screw SystemArtfx MedicalDec 23, 2024SESE
K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)Bonebridge AGDec 20, 2024SESE
K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KGDec 11, 2024SESE
K241128TDM Plate and Screw SystemTdm Co., Ltd.Dec 5, 2024SESE
K243050TriMed Posterior Malleolus Fixation SystemTriMed, Inc.Nov 26, 2024SESE
K241995HyperFlex™ Bunion Correction SystemFootbridge MedicalNov 26, 2024SESE
K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.Nov 21, 2024SESE
K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.Nov 21, 2024SESE
K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.Nov 14, 2024SESE
K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.Nov 14, 2024SESE
K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.Nov 14, 2024SESE
K240388Osteotomy Truss System (OTS)4Web Medical, Inc.Nov 1, 2024SESE
K242399Bonebridge Osteosynthesis Plating SystemBonebridge AGOct 31, 2024SESE
K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant CompanyOct 23, 2024SESE
K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.Oct 21, 2024SESE
K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.Oct 9, 2024SESE
K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating SystemStryker GmbHOct 6, 2024SESE
K242343BPS Wrist Fracture SystemOrthonovis, Inc.Oct 4, 2024SESE
K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.Sep 26, 2024SESE
K241709Pectus Blu Support Bar SystemBiomet MicrofixationSep 19, 2024SESE
K241942TriMed Bridge PlatesTriMed, Inc.Sep 17, 2024SESE
K241356Fine Osteotomy™Bodycad Laboratories, Inc.Sep 5, 2024SESE
K240487EVOS Patella PlatesSmith & NephewSep 3, 2024SESE
K233816REDEMPTION Charcot Plating SystemVilex, LLCAug 28, 2024SESE
K240318SITTER 3.5mm Versatile SystemBonebridge AGAug 23, 2024SESE
K241282RibFix Titan™ Fixation SystemRiverpoint MedicalAug 19, 2024SESE
K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft PlateZimmer Switzerland Manufacturing GmbHAug 15, 2024SESE
K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USAAug 13, 2024SESE
K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.Aug 1, 2024SESE
K241539Activmotion SNewclip TechnicsJul 30, 2024SESE
K233994VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbHJul 26, 2024SESE
K241296Gaudi Proximal Humerus PlateNetbiologics, LLCJul 23, 2024SESE
K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.Jul 12, 2024SESE
K234059Forma Medical Optimal Plating SystemForma Medical, Inc.Jun 26, 2024SESE
K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.Jun 26, 2024SESE
K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AGJun 20, 2024SESE
K230546SIGNEXOsteonic Co., Ltd.Jun 11, 2024SESE
K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.Jun 5, 2024SESE
K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLCMay 31, 2024SESE
K233089NeoSpan® Compression Implant SystemIn2bones USA, LLCMay 24, 2024SESE
K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbHMay 9, 2024SESE
K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private LimitedApr 26, 2024SESE
K233311Acumed Wrist Plating SystemAcumed, LLCApr 22, 2024SESE
K232105APTUS Foot System 2.8-3.5Medartis AGApr 19, 2024SESE
K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-TriMed, Inc.Apr 17, 2024SESE
K240703Fine Osteotomy™Bodycad Laboratories, Inc.Apr 12, 2024SESE
K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.Apr 5, 2024SESE
K233919VariAx 2 Distal Radius SystemStryker GmbHMar 25, 2024SESE
K234062APTUS Hand Scaphoid PlatesMedartis AGMar 21, 2024SESE
K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemDePuy SynthesMar 21, 2024SESE
K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.Feb 22, 2024SESE
K231213HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd.Jan 19, 2024SESE
K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LPJan 18, 2024SESE
K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.Jan 12, 2024SESE
K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLCDec 21, 2023SESE
K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLCDec 21, 2023SESE
K233017TM Plating SystemTyber Medical, LLCDec 20, 2023SESE
K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.Dec 15, 2023SESE
K231887ARIX Ankle Distal Tibia SystemJeil Medical CorporationDec 14, 2023SESE
K232652Anatomical Plating System (various)Tyber Medical, LLCDec 13, 2023SESE
K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical DevicesDec 8, 2023SESE
K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLCDec 4, 2023SESE
K230591TriLEAP Plating SystemCrossroads Extremity SystemsSep 29, 2023SESE
K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.Sep 25, 2023SESE
K230805TriMed Clavicle Fixation SystemTriMed, Inc.Sep 1, 2023SESE
K230623KITE Distal Fibula KitIntrauma S.P.ASep 1, 2023SESE
K231623Distal Elbow Plating SystemSkeletal Dynamics, Inc.Aug 28, 2023SESE
K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.Aug 24, 2023SESE
K232144Sterile Products of the APTUS SystemMedartis AGAug 18, 2023SESE
K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating SystemStryker GmbHAug 18, 2023SESE
K231257Pangea Utility Plating System, Pangea PlatformStryker GmbHAug 18, 2023SESE
K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.Aug 17, 2023SESE
K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus SystemBonebridge AGJul 19, 2023SESE
K231441ARIX Ankle SystemJeil Medical CorporationJul 17, 2023SESE
K230971APTUS® 3.5 TriLock Straight PlatesMedartis AGJun 2, 2023SESE
K223762Smith & Nephew ACCORD™ Cable SystemSmith & NephewMay 30, 2023SESE
K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.May 25, 2023SESE
K230938ARIX Humerus SystemJeil Medical CorporationMay 3, 2023SESE
K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbHApr 27, 2023SESE
K230204ALPHALOK Plating SystemVilex, LLCApr 25, 2023SESE
K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbHApr 7, 2023SESE
K223853Medartis APTUS® Ulna PlatesMedartis AGMar 30, 2023SESE
K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion SystemCrossroads Extremity Systems, LLCMar 30, 2023SESE
K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.Mar 29, 2023SESE
K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.Mar 29, 2023SESE
K221938KLS Martin Pure Pectus SystemKLS Martin L.P.Mar 28, 2023SESE
K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AGMar 17, 2023SESE
K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLCMar 7, 2023SESE
K213059Tibia and Fibula SystemAuxein Medical Private LimitedJan 27, 2023SESE
K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.Jan 25, 2023SESE
K221150Advanced Bone PlateDouble Medical Technology, Inc.Jan 25, 2023SESE
K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant CompanyJan 21, 2023SESE
K221088Anatomic Bone PlateDouble Medical Technology, Inc.Jan 18, 2023SESE
K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.Jan 5, 2023SESE
K222637TriMed Wrist Fixation System 3TriMed, Inc.Dec 21, 2022SESE
K221412ARIX Rib SystemJeil Medical CorporationNov 22, 2022SESE
K221558ALPHALOK Plating SystemVilex, LLCNov 15, 2022SESE
K213108Humerus & Ulna SystemAuxein Medical Private LimitedNov 4, 2022SESE
K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing CompanyOct 27, 2022SESE
K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.Oct 18, 2022SESE
K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.Oct 3, 2022SESE
K213014Varixis Elbow SystemAuxein Medical Private LimitedOct 3, 2022SESE
K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.Sep 30, 2022SESE
K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LPSep 27, 2022SESE
K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemDePuy SynthesSep 20, 2022SESE
K213864Bonebridge Osteosynthesis Plating SystemBonebridge AGSep 2, 2022SESE
K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbHAug 31, 2022SESE
K221920ARIX Small Fragment SystemJeil Medical CorporationAug 24, 2022SESE
K222194Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.Aug 19, 2022SESE
K221346Stryker VariAx 2 MIS CalcaneusStryker GmbHJul 8, 2022SESE
K221395Footmotion Plating SystemNewclip TechnicsJul 1, 2022SESE
K220937Arthrex Mini Fragment SystemArthrex, Inc.Jun 29, 2022SESE
K221465Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.Jun 17, 2022SESE
K221362Omni Foot and Ankle Plating SystemExremity Medical, LLCJun 10, 2022SESE
K213698CoLink PCR Plating SystemIn2bones USA, LLCMay 27, 2022SESE
K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.May 20, 2022SESE
K220463Osteotomy Truss System (OTS)4Web Medical, Inc.May 18, 2022SESE
K212782SternaLock Sternal Closure SystemBiomet MicrofixationMay 17, 2022SESE
K213837Arthrx Fracture PlatesArthrex, Inc.May 2, 2022SESE
K212348ALPHALOK™ Plating SystemVilex, LLCMay 2, 2022SESE
K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical TechApr 28, 2022SESE
K212608RibFix Blu Thoracic Fixation SystemBiomet MicrofixationApr 22, 2022SESE
K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant CompanyApr 5, 2022SESE

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