Cortical Fixation Systems
K-Number: K181086 · 2019-01-09
ApplicantCousin Biotech Sas
Decision Date2019-01-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cortical Fixation Systems is a medical device manufactured by Cousin Biotech Sas. It received FDA 510(k) clearance on 2019-01-09 under approval number K181086. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cortical Fixation Systems?
Cortical Fixation Systems is a medical device that received FDA 510(k) clearance on 2019-01-09. It is manufactured by Cousin Biotech Sas. The 510(k) number is K181086.
When was Cortical Fixation Systems approved by the FDA?
Cortical Fixation Systems received FDA 510(k) clearance on 2019-01-09, under approval number K181086.
What company makes Cortical Fixation Systems?
Cortical Fixation Systems is manufactured by Cousin Biotech Sas.
What is the FDA product code for Cortical Fixation Systems?
The FDA product code for Cortical Fixation Systems is MBI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.