K213418 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Hemostatic Bone Putty, a Wax, Bone, submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on August 30, 2023, 679 days after receiving the submission on October 20, 2021. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K213418 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2021 |
| Decision Date | August 30, 2023 |
| Days to Decision | 679 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |