The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Ti Anchor With Dynacord.
| Device ID | K183279 |
| 510k Number | K183279 |
| Device Name: | HEALIX Ti ANCHOR With DYNACORD |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medos International SARL Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
| Contact | N/a N/a |
| Correspondent | Leslie Coney DePuy 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705029983 | K183279 | 000 |
| 10886705029976 | K183279 | 000 |
| 10886705029969 | K183279 | 000 |
| 10886705029952 | K183279 | 000 |
| 10886705029945 | K183279 | 000 |
| 10886705029938 | K183279 | 000 |
| 10886705029921 | K183279 | 000 |
| 10886705029914 | K183279 | 000 |