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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) K180025 Centurion POCT SystemNKG2018-01-22 View
510(k) K172696 FORZA® XP Expandable Spacer SystemMAX2018-01-19 View
510(k) K172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemODP2017-11-02 View
510(k) K172194 Connector SystemNKG2017-08-18 View
510(k) K170647 Connector SystemNKG2017-05-11 View
510(k) K171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation SystemNKB2017-05-05 View
510(k) K162921 Navigated Instrument SystemOLO2017-03-13 View
510(k) K162446 FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemMAX2016-12-22 View
510(k) K162638 CETRA Anterior Cervical Plate SystemKWQ2016-12-16 View
510(k) K161129 PILLAR SA PTCOVD2016-09-08 View
510(k) K161280 Cervical Stand Alone SystemOVE2016-06-17 View
510(k) K153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemNKB2016-01-29 View
510(k) K152475 FORZA PTC Spacer SystemMAX2016-01-14 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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