INFINITY Total Ankle System
K-Number: K181557 · 2018-08-09
ApplicantWrightmedicaltechnologyinc
Decision Date2018-08-09
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
INFINITY Total Ankle System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2018-08-09 under approval number K181557. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the INFINITY Total Ankle System?
INFINITY Total Ankle System is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K181557.
When was INFINITY Total Ankle System approved by the FDA?
INFINITY Total Ankle System received FDA 510(k) clearance on 2018-08-09, under approval number K181557.
What company makes INFINITY Total Ankle System?
INFINITY Total Ankle System is manufactured by Wrightmedicaltechnologyinc.
What is the FDA product code for INFINITY Total Ankle System?
The FDA product code for INFINITY Total Ankle System is HSN.
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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.