FaSet Fixation System
K-Number: K222515 · 2022-10-05
ApplicantDio Medical Corporation
Decision Date2022-10-05
Product CodeMRW
DecisionSubstantially Equivalent
Device Summary
FaSet Fixation System is a medical device manufactured by Dio Medical Corporation. It received FDA 510(k) clearance on 2022-10-05 under approval number K222515. 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 2022-10-05. It is manufactured by Dio Medical Corporation. The 510(k) number is K222515.
When was FaSet Fixation System approved by the FDA?
FaSet Fixation System received FDA 510(k) clearance on 2022-10-05, under approval number K222515.
What company makes FaSet Fixation System?
FaSet Fixation System is manufactured by Dio Medical Corporation.
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.