The following data is part of a premarket notification filed by Orthocon, Inc. with the FDA for Orthostat Bone Hemostat Matrix Applicator.
| Device ID | K102762 |
| 510k Number | K102762 |
| Device Name: | ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR |
| Classification | Wax, Bone |
| Applicant | ORTHOCON, INC. 1 BRIDGE STREET, SUITE 121 Irvington, NY 10533 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst 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 | 2010-09-24 |
| Decision Date | 2011-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850391007054 | K102762 | 000 |