The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Knotless Br Anchor.
| Device ID | K180101 |
| 510k Number | K180101 |
| Device Name: | HEALIX ADVANCE KNOTLESS BR Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
| Contact | Ashley Goncalo |
| Correspondent | Ashley Goncalo DePuy Synthes Mitek, A Johnson And Johnson Company 325 Paramount Drive 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 | 2018-01-16 |
| Decision Date | 2018-05-10 |
| Summary: | summary |