INVISION Total Ankle Revision System
K-Number: K153008 · 2016-05-06
ApplicantWrightmedicaltechnologyinc
Decision Date2016-05-06
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
INVISION Total Ankle Revision System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2016-05-06 under approval number K153008. 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 INVISION Total Ankle Revision System?
INVISION Total Ankle Revision System is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K153008.
When was INVISION Total Ankle Revision System approved by the FDA?
INVISION Total Ankle Revision System received FDA 510(k) clearance on 2016-05-06, under approval number K153008.
What company makes INVISION Total Ankle Revision System?
INVISION Total Ankle Revision System is manufactured by Wrightmedicaltechnologyinc.
What is the FDA product code for INVISION Total Ankle Revision System?
The FDA product code for INVISION Total Ankle Revision 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.