K253447 is an FDA 510(k) clearance for the Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover). This device is classified as a Cover, Burr Hole (Class II - Special Controls, product code GXR).
Submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on March 16, 2026, 165 days after receiving the submission on October 2, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5250.
| 510(k) Number | K253447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2025 |
| Decision Date | March 16, 2026 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXR — Cover, Burr Hole |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5250 |