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OrthoPediatrics Corp. FDA Approvals
0 new drug approvals and 16 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 |
|---|
| Pediatric Nailing Platform Femur510(k)Sep 24, 2026Orthopedic |
| OrthoPediatrics® Locking Cannulated Blade Plate System510(k)Apr 30, 2026Orthopedic |
| Pediatric Plating Platform I Small-Mini510(k)Oct 9, 2025Orthopedic |
| PediFlex Flexible Nail System510(k)Jun 24, 2025Orthopedic |
| Pediatric Plating Platform Hip510(k)Apr 29, 2025Orthopedic |
| Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur510(k)Apr 1, 2025Orthopedic |
| VerteGlide Spinal Growth Guidance System510(k)Mar 14, 2025Orthopedic |
| Orthex External Fixation System510(k)Mar 7, 2025Orthopedic |
| RESPONSE Rib and Pelvic System510(k)Jan 20, 2024Orthopedic |
| Pediatric Nailing Platform Tibia510(k)Aug 21, 2023Orthopedic |
| RESPONSE 5.5/6.0 Cannulated Screw System510(k)Mar 23, 2023Orthopedic |
| Orthex External Fixation System510(k)Feb 10, 2023Orthopedic |
| Pediatric Nailing Platform Femur510(k)Jul 20, 2022Orthopedic |
| Drive Rail System510(k)Apr 8, 2022Orthopedic |
| RESPONSE Navigation Instruments510(k)Feb 4, 2021Neurology |
| PediFlex Flexible Nail System510(k)Jan 29, 2021Orthopedic |