510(k) K253615 ยท OWI Bone Fixation Cerclage, Sublaminar
Invictus Bands System
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 25, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253615
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.