The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Dyna+tape Sutures.
| Device ID | K191483 |
| 510k Number | K191483 |
| Device Name: | HEALIX ADVANCE Anchor With DYNA+TAPE Sutures |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-04 |
| Decision Date | 2019-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705030941 | K191483 | 000 |
| 10886705030842 | K191483 | 000 |
| 10886705030859 | K191483 | 000 |
| 10886705030866 | K191483 | 000 |
| 10886705030873 | K191483 | 000 |
| 10886705030880 | K191483 | 000 |
| 10886705030897 | K191483 | 000 |
| 10886705030903 | K191483 | 000 |
| 10886705030910 | K191483 | 000 |
| 10886705030927 | K191483 | 000 |
| 10886705030934 | K191483 | 000 |
| 10886705030835 | K191483 | 000 |