The following data is part of a premarket notification filed by Medos International Sarl with the FDA for 6.5 Mm Healix Advance Sp Peek Anchor, 6.5 Mm Healix Advance Sp Biocomposite Anchor.
| Device ID | K201883 |
| 510k Number | K201883 |
| Device Name: | 6.5 Mm Healix Advance SP Peek Anchor, 6.5 Mm Healix Advance SP Biocomposite Anchor |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-08 |
| Decision Date | 2020-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705030620 | K201883 | 000 |
| 10886705030613 | K201883 | 000 |