The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for 4.5mm Healix Ti Anchor, With 2 Or 3 Strands Of #2 Permacord Suture, 5.5mm Healix Ti Anchor, With 2 Or 3 Strands Of #2 Permacord Suture, 6.5mm Healix Ti Anchor, With 2 Or 3 Strands Of #2 Permacord Suture,.
| Device ID | K142574 |
| 510k Number | K142574 |
| Device Name: | 4.5mm Healix Ti Anchor, With 2 Or 3 Strands Of #2 Permacord Suture, 5.5mm Healix Ti Anchor, With 2 Or 3 Strands Of #2 Permacord Suture, 6.5mm Healix Ti Anchor, With 2 Or 3 Strands Of #2 Permacord Suture, |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Tracey Hannon |
| Correspondent | Tracey Hannon 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2014-10-24 |
| Summary: | summary |