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Orthofix, Inc.

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

Total Devices33
Categories11
Latest Approval2024-05-28
TypeNumberDevice NameCodeDate
510(k) K240749 PILLAR SA Ti Spacer System (82-XXX) MAX 2024-05-28 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 System ODP 2021-08-31 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 System NKG 2021-07-30 View
510(k) K210667 FIREBIRD SI Fusion System OUR 2021-03-25 View
510(k) K203342 CONSTRUX Mini Ti Spacer System ODP 2021-03-18 View
510(k) K203576 FORZA Ti Spacer System MAX 2021-03-03 View
510(k) K203138 FIREBIRD SI Fusion System OUR 2020-11-18 View
510(k) K202949 CONSTRUX Mini PEEK Spacer System ODP 2020-10-29 View
510(k) K202666 CONSTRUX Mini PTC Spacer System ODP 2020-10-14 View
510(k) K201664 FIREBIRD SI Fusion System OUR 2020-09-15 View
510(k) K201481 Centurion POCT System NKG 2020-06-15 View
510(k) K200606 O-Genesis Graft Delivery System FMF 2020-05-01 View
510(k) K200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System ODP 2020-04-09 View
510(k) K200696 FIREBIRD SI Fusion System OUR 2020-04-02 View
510(k) K190751 Connector System NKG 2019-05-22 View
510(k) K183342 SambaScrew 3D SI Fusion System OUR 2019-04-30 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 Screw NKB 2018-08-24 View
510(k) K172115 Navigated Instrument System OLO 2018-03-08 View
510(k) K180025 Centurion POCT System NKG 2018-01-22 View
510(k) K172696 FORZA® XP Expandable Spacer System MAX 2018-01-19 View
510(k) K172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System ODP 2017-11-02 View
510(k) K172194 Connector System NKG 2017-08-18 View
510(k) K170647 Connector System NKG 2017-05-11 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 System NKB 2017-05-05 View
510(k) K162921 Navigated Instrument System OLO 2017-03-13 View
510(k) K162446 FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System MAX 2016-12-22 View
510(k) K162638 CETRA Anterior Cervical Plate System KWQ 2016-12-16 View
PMA P030034 Stimulator, bone growth, non-invasive LOF 2016-12-02 View
PMA P850007 Stimulator, bone growth, non-invasive LOF 2016-12-02 View
510(k) K161129 PILLAR SA PTC OVD 2016-09-08 View
510(k) K161280 Cervical Stand Alone System OVE 2016-06-17 View
510(k) K153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System NKB 2016-01-29 View
510(k) K152475 FORZA PTC Spacer System MAX 2016-01-14 View
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