The following data is part of a premarket notification filed by Depuy Mitek, A Johnson And Johnson Company with the FDA for Healix Br Anchor, Healix Peek Anchor, Healix Transtend, Gryphon T And P Br Anchor, Gryphon Peek Anchor, Versalok Anchor, Bioknotless Br Anchor, Lupine Br Anchor, Panalok Anchor,panalok Anchor With Orthocord, Panalok Rc Quickanchor Plus; Panalok Rc Qu.
| Device ID | K150209 |
| 510k Number | K150209 |
| Device Name: | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T And P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor With Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC Qu |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Depuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham, MA 02767 |
| Contact | Yayoi Fujimaki |
| Correspondent | Yayoi Fujimaki Depuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MAI |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-10-06 |