510(k) K253854 ยท GXP Methyl Methacrylate For Cranioplasty
MONTAGE XT Cranial Cement
| Applicant | Orthocon, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Jan 2, 2026 |
| Received | Dec 3, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253854
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.