The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Healix Advance Knotless Peek Anchor (4.75mm)(5.5mm).
| Device ID | K130539 |
| 510k Number | K130539 |
| Device Name: | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Julie Vafides |
| Correspondent | Julie Vafides DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-01 |
| Decision Date | 2013-05-21 |
| Summary: | summary |