The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Rotator Cuff Quickanchor Plus.
| Device ID | K992611 |
| 510k Number | K992611 |
| Device Name: | MITEK ROTATOR CUFF QUICKANCHOR PLUS |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Christine Kuntz-nassif |
| Correspondent | Christine Kuntz-nassif MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-04 |
| Decision Date | 1999-09-22 |
| Summary: | summary |