The following data is part of a premarket notification filed by Cousin Biotech S.a.s. with the FDA for Cortical Fixation Systems.
| Device ID | K181086 |
| 510k Number | K181086 |
| Device Name: | Cortical Fixation Systems |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Cousin Biotech S.A.S. 8 Rue De L'abbe Bonpain Wervicq-sud, FR 59117 |
| Contact | Mathilde Collet |
| Correspondent | Franck Pelletier Cousin Biotech S.A.S. 8 Rue De L'abbe Bonpain Wervicq-sud, FR 59117 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-25 |
| Decision Date | 2019-01-09 |
| Summary: | summary |