K231475 is an FDA 510(k) clearance for the MONTAGE-QS Settable, Resorbable Bone Putty. This device is classified as a Methyl Methacrylate For Cranioplasty (Class II - Special Controls, product code GXP).
Submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on October 12, 2023, 143 days after receiving the submission on May 22, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5300.
| 510(k) Number | K231475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2023 |
| Decision Date | October 12, 2023 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXP — Methyl Methacrylate For Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5300 |