ZUK Select Knee System
K-Number: K160738 · 2016-06-15
ApplicantSmith & Nephew, Inc.
Decision Date2016-06-15
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ZUK Select Knee System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-06-15 under approval number K160738. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ZUK Select Knee System?
ZUK Select Knee System is a medical device that received FDA 510(k) clearance on 2016-06-15. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K160738.
When was ZUK Select Knee System approved by the FDA?
ZUK Select Knee System received FDA 510(k) clearance on 2016-06-15, under approval number K160738.
What company makes ZUK Select Knee System?
ZUK Select Knee System is manufactured by Smith & Nephew, Inc..
What is the FDA product code for ZUK Select Knee System?
The FDA product code for ZUK Select Knee System is HSX.
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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.