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Orthofix Srl

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories8
Latest FDA decision2026-05-19
TypeNumberDevice NameCodeDateActions
510(k) K260146 FITBONE® TRANSPORT AND LENGTHENING SYSTEMHSB2026-05-19 View
510(k) K253991 Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB2026-05-08 View
510(k) K250112 FitboneTM TrochantericHSB2025-04-10 View
510(k) K242270 OrthoNext Platform SystemQIH2024-12-19 View
510(k) K242861 TrueLok ElevateKTT2024-12-03 View
510(k) K233867 Fitbone TrochantericHSB2024-06-18 View
510(k) K232648 RODEO Telescopic NailHSB2024-05-03 View
510(k) K232169 FITBONE® Transport and Lengthening SystemHSB2024-03-22 View
510(k) K213572 JuniOrtho Plating System™HWC2022-01-18 View
510(k) K212044 TrueLok EvoKTT2021-11-05 View
510(k) K210157 SOLE Medial Column Fusion PlateHRS2021-04-20 View
510(k) K202519 OrthoNext Platform SystemLLZ2020-10-27 View
510(k) K200246 JPS JuniOrtho Plating SystemHRS2020-05-22 View
510(k) K190388 RIVAL View Plating Systems and Reduce Fracture Plating SystemsHRS2019-06-07 View
510(k) K180624 Guided Growth Plate System PlusOBT2018-05-15 View
510(k) K172699 Agile NailHSB2018-04-23 View
510(k) K172698 G-Beam Fusion Beaming SystemHWC2018-02-07 View
510(k) K172183 Guided Growth Plate System PlusOBT2018-01-09 View
510(k) K173458 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemHSB2017-12-07 View
510(k) K173051 Orthofix MJ-FLEX THE NEW METAIZEAU NAILHTY2017-11-16 View

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