FDA 510(k) Applications Submitted by Orthofix Srl

FDA 510(k) Number Submission Date Device Name Applicant
K051945 07/18/2005 MIOT PLATING SYSTEM ORTHOFIX SRL
K122541 08/21/2012 ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) ORTHOFIX SRL
K062920 09/28/2006 ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP ORTHOFIX SRL
K053261 11/22/2005 ORTHOFIX TITANIUM NAILING SYSTEMS ORTHOFIX SRL
K113770 12/22/2011 ORTHOFIX GALAXY FIXATION SYSTEM ORTHOFIX SRL
K141078 04/25/2014 ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) ORTHOFIX SRL
K141760 07/01/2014 ORTHOFIX GALAXY WRIST ORTHOFIX SRL
K142052 07/28/2014 ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT ORTHOFIX SRL
K170146 01/17/2017 Galaxy UNYCO System Orthofix Srl
K210157 01/21/2021 SOLE Medial Column Fusion Plate Orthofix SRL
K200246 01/31/2020 JPS JuniOrtho Plating System Orthofix Srl
K190388 02/19/2019 RIVAL View Plating Systems and Reduce Fracture Plating Systems Orthofix Srl
K170650 03/03/2017 Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl
K180624 03/09/2018 Guided Growth Plate System Plus Orthofix Srl
K161466 05/27/2016 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System ORTHOFIX SRL
K212044 06/30/2021 TrueLok Evo Orthofix SRL
K172183 07/19/2017 Guided Growth Plate System Plus Orthofix Srl
K152171 08/04/2015 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 ORTHOFIX SRL
K202519 09/01/2020 OrthoNext Platform System Orthofix Srl
K172698 09/07/2017 G-Beam Fusion Beaming System Orthofix Srl
K172699 09/07/2017 Agile Nail Orthofix Srl
K173051 09/28/2017 Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl
K143125 10/31/2014 Orthofix True Lok Hexapod System VI.3 Orthofix Srl
K173458 11/07/2017 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl
K153233 11/09/2015 Galaxy UNYCO System ORTHOFIX SRL
K213572 11/10/2021 JuniOrtho Plating SystemÖ Orthofix Srl
K973944 10/16/1997 ORTHOFIX FEMORAL NAILING SYTEM ORTHOFIX SRL
K974186 11/07/1997 ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING ORTHOFIX SRL
K141571 06/12/2014 ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM ORTHOFIX SRL


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