510(k) K253145 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Pre-Sutured Tendon
| Applicant | Rti Surgical, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, Oct 22, 2025 |
| Received | Sep 25, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253145
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.