510(k) K230036 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
| Applicant | Rti Surgical, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, Jun 23, 2023 |
| Received | Dec 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230036
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.