The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Mini Anchor.
| Device ID | K992623 |
| 510k Number | K992623 |
| Device Name: | MITEK MINI ANCHOR |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Paula E Bulger |
| Correspondent | Paula E Bulger MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-05 |
| Decision Date | 1999-11-02 |
| Summary: | summary |