The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Knotless Anchor.
| Device ID | K171114 |
| 510k Number | K171114 |
| Device Name: | HEALIX ADVANCE KNOTLESS Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
| Contact | Julie Vafides |
| Correspondent | Julie Vafides DePuy 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 | 2017-04-14 |
| Decision Date | 2017-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705030354 | K171114 | 000 |
| 10886705030347 | K171114 | 000 |
| 10886705030330 | K171114 | 000 |