The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Bioknotless And Lupine Plus Anchors.
| Device ID | K062170 |
| 510k Number | K062170 |
| Device Name: | BIOKNOTLESS AND LUPINE PLUS ANCHORS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705001057 | K062170 | 000 |
| 10886705001071 | K062170 | 000 |
| 10886705001064 | K062170 | 000 |