K253145 is an FDA 510(k) clearance for the Pre-Sutured Tendon. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on October 22, 2025, 27 days after receiving the submission on September 25, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K253145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2025 |
| Decision Date | October 22, 2025 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |