The following data is part of a premarket notification filed by Abanza Tecnomed Sl. with the FDA for Washercap Fixation System.
| Device ID | K212197 |
| 510k Number | K212197 |
| Device Name: | WasherCap Fixation System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Abanza Tecnomed SL. Calle Nueva 8-11 Mutilva, ES 31192 |
| Contact | Aitor Olaso |
| Correspondent | Aitor Olaso Abanza Tecnomed SL. Calle Nueva 8-11 Mutilva, ES 31192 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-14 |
| Decision Date | 2022-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437019739843 | K212197 | 000 |
| 08437019739836 | K212197 | 000 |
| 08437019739829 | K212197 | 000 |
| 08437019739812 | K212197 | 000 |