K203855 is an FDA 510(k) clearance for the CoNextions TR Tendon Repair System. This device is classified as a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II - Special Controls, product code GAQ).
Submitted by Conextions Medical (Salt Lake City, US). The FDA issued a Cleared decision on April 22, 2022, 477 days after receiving the submission on December 31, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4495.
| 510(k) Number | K203855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2020 |
| Decision Date | April 22, 2022 |
| Days to Decision | 477 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAQ - Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4495 |