The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Gii Quickanchor Plus With Orthocord Suture.
| Device ID | K051989 |
| 510k Number | K051989 |
| Device Name: | GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE |
| Classification | Staple, 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-22 |
| Decision Date | 2005-08-05 |
| Summary: | summary |