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Orthofix Srl

38 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146)Orthofix Srl2026-05-19
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991)Orthofix Srl2026-05-08
FitboneTM Trochanteric (K250112)Orthofix Srl2025-04-10
OrthoNext Platform System (K242270)Orthofix Srl2024-12-19
TrueLok Elevate (K242861)Orthofix Srl2024-12-03
Fitbone Trochanteric (K233867)Orthofix Srl2024-06-18
RODEO Telescopic Nail (K232648)Orthofix Srl2024-05-03
FITBONE® Transport and Lengthening System (K232169)Orthofix Srl2024-03-22
JuniOrtho Plating System™ (K213572)Orthofix Srl2022-01-18
TrueLok Evo (K212044)Orthofix Srl2021-11-05
SOLE Medial Column Fusion Plate (K210157)Orthofix Srl2021-04-20
OrthoNext Platform System (K202519)Orthofix Srl2020-10-27
JPS JuniOrtho Plating System (K200246)Orthofix Srl2020-05-22
RIVAL View Plating Systems and Reduce Fracture Plating Systems (K190388)Orthofix Srl2019-06-07
Guided Growth Plate System Plus (K180624)Orthofix Srl2018-05-15
Agile Nail (K172699)Orthofix Srl2018-04-23
G-Beam Fusion Beaming System (K172698)Orthofix Srl2018-02-07
Guided Growth Plate System Plus (K172183)Orthofix Srl2018-01-09
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K173458)Orthofix Srl2017-12-07
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL (K173051)Orthofix Srl2017-11-16
Galaxy UNYCO System (K170146)Orthofix Srl2017-10-12
Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (K170650)Orthofix Srl2017-05-10
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System (K161466)Orthofix Srl2017-01-24
Galaxy UNYCO System (K153233)Orthofix Srl2016-01-06
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (K152171)Orthofix Srl2015-09-28
Orthofix True Lok Hexapod System VI.3 (K143125)Orthofix Srl2014-12-10
ORTHOFIX GALAXY WRIST (K141760)Orthofix Srl2014-12-08
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT (K142052)Orthofix Srl2014-12-05
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM (K141571)Orthofix Srl2014-11-12
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) (K141078)Orthofix Srl2014-09-02
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541)Orthofix Srl2012-09-20
ORTHOFIX GALAXY FIXATION SYSTEM (K113770)Orthofix Srl2012-09-04
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (K062920)Orthofix Srl2006-11-13
ORTHOFIX TITANIUM NAILING SYSTEMS (K053261)Orthofix Srl2005-12-12
MIOT PLATING SYSTEM (K051945)Orthofix Srl2005-09-06
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING (K974186)Orthofix Srl1998-03-18
ORTHOFIX FEMORAL NAILING SYTEM (K973944)Orthofix Srl1997-12-19
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM (K944092)Orthofix Srl1995-04-04

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Every clearance here is in the API, with alerts when new ones post.