The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Healix Advance Knotless Br Anchor (6.5mm).
| Device ID | K131974 |
| 510k Number | K131974 |
| Device Name: | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2013-07-25 |
| Summary: | summary |