The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Dynatape Suture.
| Device ID | K200949 |
| 510k Number | K200949 |
| Device Name: | HEALIX ADVANCE 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 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 | 2020-04-09 |
| Decision Date | 2020-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705031115 | K200949 | 000 |
| 10886705031016 | K200949 | 000 |
| 10886705031023 | K200949 | 000 |
| 10886705031030 | K200949 | 000 |
| 10886705031047 | K200949 | 000 |
| 10886705031054 | K200949 | 000 |
| 10886705031061 | K200949 | 000 |
| 10886705031078 | K200949 | 000 |
| 10886705031085 | K200949 | 000 |
| 10886705031092 | K200949 | 000 |
| 10886705031108 | K200949 | 000 |
| 10886705031009 | K200949 | 000 |