Coronet Soft Tissue Fixation System
K-Number: K200028 · 2020-03-04
ApplicantConextions Medical
Decision Date2020-03-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Coronet Soft Tissue Fixation System is a medical device manufactured by Conextions Medical. It received FDA 510(k) clearance on 2020-03-04 under approval number K200028. 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 Coronet Soft Tissue Fixation System?
Coronet Soft Tissue Fixation System is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by Conextions Medical. The 510(k) number is K200028.
When was Coronet Soft Tissue Fixation System approved by the FDA?
Coronet Soft Tissue Fixation System received FDA 510(k) clearance on 2020-03-04, under approval number K200028.
What company makes Coronet Soft Tissue Fixation System?
Coronet Soft Tissue Fixation System is manufactured by Conextions Medical.
What is the FDA product code for Coronet Soft Tissue Fixation System?
The FDA product code for Coronet Soft Tissue Fixation System 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.