K221031 is an FDA 510(k) clearance for the Arthrex DualCompression Hindfoot Fusion Nail Implant System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 20, 2022, 257 days after receiving the submission on April 7, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K221031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2022 |
| Decision Date | December 20, 2022 |
| Days to Decision | 257 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 |