510(k) K253447 ยท GXR Cover, Burr Hole
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
| Applicant | Orthocon, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Mar 16, 2026 |
| Received | Oct 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253447
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.