The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Gii Quickanchor Plus.
| Device ID | K041115 |
| 510k Number | K041115 |
| Device Name: | GII QUICKANCHOR PLUS |
| Classification | Staple, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Allyson Barford |
| Correspondent | Allyson Barford 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 | 2004-04-29 |
| Decision Date | 2004-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705008612 | K041115 | 000 |
| 10886705001828 | K041115 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GII QUICKANCHOR PLUS 76577706 2932531 Live/Registered |
JOHNSON & JOHNSON 2004-02-26 |