The following data is part of a premarket notification filed by Mitek Products with the FDA for Resolve Quickanchor.
| Device ID | K993575 |
| 510k Number | K993575 |
| Device Name: | RESOLVE QUICKANCHOR |
| 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 | 1999-10-21 |
| Decision Date | 1999-12-29 |
| Summary: | summary |