The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for 4.5mm Healix Advance Br Anchor, With 2 Or 3 Strands Of #2 Permacord Suture, 5.5mm Healix Advance Br Anchor, With 2 Or 3.
| Device ID | K133794 |
| 510k Number | K133794 |
| Device Name: | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Tatyana Korsunsky |
| Correspondent | Tatyana Korsunsky 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-13 |
| Decision Date | 2014-02-04 |
| Summary: | summary |