510(k) K250021 ยท OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Rotium
| Applicant | Nanofiber Solutions, LLC, Dublin OH, US |
| Decision | Substantially Equivalent, Feb 27, 2025 |
| Received | Jan 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250021
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.