The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Biofastin Rc Threaded Suture Anchor.
| Device ID | K021883 |
| 510k Number | K021883 |
| Device Name: | BIOFASTIN RC THREADED SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HWC |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAS |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2002-07-01 |
| Summary: | summary |