FaSet Fixation System
K-Number: K180729 · 2018-06-28
ApplicantHuvexel Co. , Ltd.
Decision Date2018-06-28
Product CodeMRW
DecisionSubstantially Equivalent
Device Summary
FaSet Fixation System is a medical device manufactured by Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2018-06-28 under approval number K180729. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FaSet Fixation System?
FaSet Fixation System is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K180729.
When was FaSet Fixation System approved by the FDA?
FaSet Fixation System received FDA 510(k) clearance on 2018-06-28, under approval number K180729.
What company makes FaSet Fixation System?
FaSet Fixation System is manufactured by Huvexel Co. , Ltd..
What is the FDA product code for FaSet Fixation System?
The FDA product code for FaSet Fixation System is MRW.
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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.