Infinity-Lock Button System
K-Number: K180243 · 2018-04-03
ApplicantXiros, Ltd.
Decision Date2018-04-03
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Infinity-Lock Button System is a medical device manufactured by Xiros, Ltd.. It received FDA 510(k) clearance on 2018-04-03 under approval number K180243. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infinity-Lock Button System?
Infinity-Lock Button System is a medical device that received FDA 510(k) clearance on 2018-04-03. It is manufactured by Xiros, Ltd.. The 510(k) number is K180243.
When was Infinity-Lock Button System approved by the FDA?
Infinity-Lock Button System received FDA 510(k) clearance on 2018-04-03, under approval number K180243.
What company makes Infinity-Lock Button System?
Infinity-Lock Button System is manufactured by Xiros, Ltd..
What is the FDA product code for Infinity-Lock Button System?
The FDA product code for Infinity-Lock Button System is HTN.
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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.