K234128 is an FDA 510(k) clearance for the Phantom Fibula Nail System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on August 22, 2024, 238 days after receiving the submission on December 28, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K234128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2023 |
| Decision Date | August 22, 2024 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |