510(k) K181086
K181086 is an FDA 510(k) premarket notification submitted by Cousin Biotech Sas for the device "Cortical Fixation Systems". The FDA issued a decision of Substantially Equivalent on January 9, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Cousin Biotech Sas has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2019
- Date Received
- April 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type