The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Threaded Anchor (fastin).
| Device ID | K953560 |
| 510k Number | K953560 |
| Device Name: | MITEK THREADED ANCHOR (FASTIN) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1996-01-31 |