The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Rotator Cuff Quickanchor Plus (with Orthocord Suture).
| Device ID | K052630 |
| 510k Number | K052630 |
| Device Name: | ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Denise Luciano |
| Correspondent | Denise Luciano DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2005-10-17 |
| Summary: | summary |