The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Hemasorbplus Resorbable Hemostatic Bone Putty.
| Device ID | K153317 |
| 510k Number | K153317 |
| Device Name: | HEMASORBPLUS Resorbable Hemostatic Bone Putty |
| Classification | Wax, Bone |
| Applicant | ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington, NY 10533 |
| Contact | Howard L. Schrayer |
| Correspondent | Howard L. Schrayer ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington, NY 10533 |
| 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 | 2015-11-18 |
| Decision Date | 2016-11-30 |
| Summary: | summary |