The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Ti Dual Threaded Suture Anchor With Dynatape Suture.
| Device ID | K203794 |
| 510k Number | K203794 |
| Device Name: | HEALIX Ti Dual Threaded Suture Anchor With DYNATAPE Suture |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medos International Sarl Chemin-Blanc 38, Case Postale Le Locle, CH Ch 2400 |
| Contact | Elizabeth Messana |
| Correspondent | Elizabeth Messana Depuy Synthes Mitek, A Johnson & 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 | 2020-12-28 |
| Decision Date | 2021-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705031177 | K203794 | 000 |
| 10886705031160 | K203794 | 000 |
| 10886705031153 | K203794 | 000 |
| 10886705031146 | K203794 | 000 |
| 10886705031139 | K203794 | 000 |
| 10886705031122 | K203794 | 000 |