510(k) K231475 ยท GXP Methyl Methacrylate For Cranioplasty
MONTAGE-QS Settable, Resorbable Bone Putty
| Applicant | Orthocon, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Oct 12, 2023 |
| Received | May 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231475
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.