510(k) K253216 ยท SIN Automated Intraoperative Spinal Rod Bending System
IntraOp Alignment System; CONTOUR3D Bending System
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 25, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253216
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.