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Orthofix, Inc.

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories11
Latest FDA decision2024-05-28
TypeNumberDevice NameCodeDateActions
510(k) K240749 PILLAR SA Ti Spacer System (82-XXX)MAX2024-05-28 View
PMA P030034 Stimulator, bone growth, non-invasiveLOF2022-06-14 View
PMA P850007 Stimulator, bone growth, non-invasiveLOF2022-06-14 View
510(k) K211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion SystemODP2021-08-31 View
510(k) K211710 Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion SystemNKG2021-07-30 View
510(k) K210667 FIREBIRD SI Fusion SystemOUR2021-03-25 View
510(k) K203342 CONSTRUX Mini Ti Spacer SystemODP2021-03-18 View
510(k) K203576 FORZA Ti Spacer SystemMAX2021-03-03 View
510(k) K203138 FIREBIRD SI Fusion SystemOUR2020-11-18 View
510(k) K202949 CONSTRUX Mini PEEK Spacer SystemODP2020-10-29 View
510(k) K202666 CONSTRUX Mini PTC Spacer SystemODP2020-10-14 View
510(k) K201664 FIREBIRD SI Fusion SystemOUR2020-09-15 View
510(k) K201481 Centurion POCT SystemNKG2020-06-15 View
510(k) K200606 O-Genesis Graft Delivery SystemFMF2020-05-01 View
510(k) K200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemODP2020-04-09 View
510(k) K200696 FIREBIRD SI Fusion SystemOUR2020-04-02 View
510(k) K190751 Connector SystemNKG2019-05-22 View
510(k) K183342 SambaScrew 3D SI Fusion SystemOUR2019-04-30 View
510(k) K180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated ScrewNKB2018-08-24 View
510(k) K172115 Navigated Instrument SystemOLO2018-03-08 View

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Related Clinical Trials

NCT07282067Orthofix PhysioStim PEMF Ankle Fusion RetrospectiveACTIVE_NOT_RECRUITINGNCT06690437Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY StudyTERMINATED
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