Cortical Fixation Systems— 510(k) K181086

Substantially Equivalent

Cousin Biotech Sas

FDA 510(k) clearance K181086 for Cortical Fixation Systems, Substantially Equivalent on 2019-01-09. Applicant: Cousin Biotech Sas.

Clearance details

Applicant: Cousin Biotech Sas
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2018-04-25
Decision date: 2019-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wervicq-Sud, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.