510(k) K253129 · NKG Posterior Cervical Screw System
Infinity OCT System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Oct 24, 2025 |
| Received | Sep 25, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253129
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.