K230976 is an FDA 510(k) clearance for the Arthrex Radiopaque FiberTape Cerclage sutures. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 24, 2023, 141 days after receiving the submission on April 5, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.
| 510(k) Number | K230976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2023 |
| Decision Date | August 24, 2023 |
| Days to Decision | 141 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 |