Product code HRS

Current FDA Classification

Device name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3030
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026-05-09
K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026-04-30
K260411PC Fix SystemChest Wall Innovations, Inc.2026-04-24
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24
K260054I.T.S. PRS Phoenix III.T.S. GmbH2026-04-24
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.2026-04-10
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.2026-04-01
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026-03-25
K260274Airlock® Ankle Plating SystemNovastep SAS2026-03-25
K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG2026-03-24
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.2026-03-23
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.2026-03-19
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-03-17
K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.2026-03-17
K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG2026-03-16
K253906Xpert HandNewclip Technics2026-03-11
K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH2026-03-09
K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.2026-03-03
K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH2026-03-02
K254249HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd.2026-02-27
K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.2026-02-26
K254162KLS Martin Ixos SystemKLS Martin L.P.2026-02-20
K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.2026-02-20
K251732Wrist Fracture SystemMet One Technologies, LLC2026-02-12
K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.2026-01-21
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.2026-01-15
K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.2026-01-12
K253178TRILEAP Plating SystemCrossroads Extremity Systems2026-01-06
K251050Pectus Versa SystemGm Dos Reis Industria E Comercio2025-12-19
K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG2025-12-17

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