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Orthofix, Inc. FDA Approvals
0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| PILLAR SA Ti Spacer System (82-XXX)510(k)May 28, 2024Orthopedic |
| 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 System510(k)Aug 31, 2021Orthopedic |
| 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 System510(k)Jul 30, 2021Orthopedic |
| FIREBIRD SI Fusion System510(k)Mar 25, 2021Orthopedic |
| CONSTRUX Mini Ti Spacer System510(k)Mar 18, 2021Orthopedic |
| FORZA Ti Spacer System510(k)Mar 3, 2021Orthopedic |