The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Mini Quickanchor And Quickanchor Plus With Orthocord.
| Device ID | K071257 |
| 510k Number | K071257 |
| Device Name: | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD |
| Classification | Staple, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kristine Christo |
| Correspondent | Kristine Christo DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JDR |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-04 |
| Decision Date | 2007-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705002436 | K071257 | 000 |
| 10886705002429 | K071257 | 000 |
| 10886705002382 | K071257 | 000 |
| 10886705001866 | K071257 | 000 |
| 10886705001835 | K071257 | 000 |