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Paragon 28, Inc. FDA Approvals
0 new drug approvals and 37 device clearances on file. Matched by name to FNA.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Primal K-Wire (P99-193-1410)510(k)Aug 28, 2026Orthopedic |
| Megalodon Dynamic Compression System510(k)Aug 6, 2026Orthopedic |
| Grappler Suture Anchor System510(k)Aug 3, 2026Orthopedic |
| Grappler Suture Anchor PCFD Tether System510(k)Mar 17, 2026Orthopedic |
| Phantom® Hindfoot TTC/TC Nail System510(k)Mar 5, 2026Orthopedic |
| Monkey Rings External Ring Fixation System510(k)Dec 19, 2025Orthopedic |
| External Fixation Mini Rail System510(k)Sep 30, 2025Orthopedic |
| External Fixation Bone Distractor510(k)Aug 11, 2025Orthopedic |
| Baby Gorilla®/Gorilla® Plating System510(k)Jul 18, 2025Orthopedic |
| Phantom® Hindfoot TTC/TC Nail System510(k)Jul 14, 2025Orthopedic |
| APEX 3D Total Ankle Replacement System510(k)May 1, 2025Orthopedic |
| Monkey Bars Pin to Bar External Fixation System510(k)Nov 1, 2024Orthopedic |
| Phantom Fibula Nail System510(k)Aug 22, 2024Orthopedic |
| Grappler Interference Screw System510(k)Jul 25, 2024Orthopedic |
| APEX 3D Total Ankle Replacement System510(k)Jun 24, 2024Orthopedic |
| Baby Gorilla/Gorilla Plating System; Monster Screw System510(k)Jun 5, 2024Orthopedic |
| Grappler Suture Anchor R3FLEX IOL System510(k)Mar 26, 2024Orthopedic |
| MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices510(k)Oct 12, 2023Orthopedic |
| Monkey RingsTM External Fixation System510(k)Oct 12, 2023Orthopedic |
| TITAN 3-D Wedge System510(k)Aug 22, 2023Orthopedic |
| Grappler Suture Anchor System510(k)Aug 21, 2023Orthopedic |
| JAWS Nitinol Staple System510(k)May 11, 2023Orthopedic |
| Grappler Suture Anchor R3FLEX IOL System510(k)Mar 3, 2023Orthopedic |
| JAWS Nitinol Staple System510(k)Feb 16, 2023Orthopedic |
| Phantom Metatarsal Shortening System510(k)Dec 16, 2022Orthopedic |
| MAVEN Patient-Specific Instrumentation510(k)Nov 17, 2022Orthopedic |
| Grappler Suture Anchor System510(k)Sep 14, 2022Orthopedic |
| Baby Gorilla®/Gorilla® Plating System510(k)Aug 19, 2022Orthopedic |
| Baby Gorilla/Gorilla Plating System510(k)Jun 17, 2022Orthopedic |
| R3ACT Stabilization System510(k)Dec 25, 2021Orthopedic |
| Paragon 28 External Ring Fixation System510(k)Nov 8, 2021Orthopedic |
| Paratrooper Plantar Plate Repair System510(k)Aug 30, 2021Orthopedic |
| Grappler Suture Anchor System510(k)Jul 7, 2021Orthopedic |
| Phantom Hindfoot TTC/TC Nail System510(k)Jun 28, 2021Orthopedic |
| Apex 3D Total Ankle Replacement System510(k)Mar 6, 2021Orthopedic |
| TenoTac Soft Tissue Fixation System510(k)Feb 11, 2021Orthopedic |
| Maven Patient-Specific Instrumentation510(k)Jan 14, 2021Orthopedic |