K212990 is an FDA 510(k) clearance for the Acumed Ankle Syndesmosis Repair System. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on January 7, 2022, 109 days after receiving the submission on September 20, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K212990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTN — Washer, Bolt Nut |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |