The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Montage-xt Settable, Resorbable Hemostatic Bone Putty.
| Device ID | K220315 |
| 510k Number | K220315 |
| Device Name: | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty |
| Classification | Wax, Bone |
| Applicant | Orthocon, Inc. 1 Bridge Street, Suite 121 Irvington, NY 10533 |
| Contact | Aniq Darr |
| Correspondent | Howard Schrayer Orthocon, Inc. 8 Lookout Hilton Head Island, SC 29928 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-03 |
| Decision Date | 2022-03-11 |