K220765 is an FDA 510(k) clearance for the HS Fiber Cerclage. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on July 26, 2023, 497 days after receiving the submission on March 16, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K220765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2022 |
| Decision Date | July 26, 2023 |
| Days to Decision | 497 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDQ — Cerclage, Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3010 |