Decision Date2016-01-05
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
K2M Fenestrated Tap System is a medical device manufactured by K2m. It received FDA 510(k) clearance on 2016-01-05 under approval number K152872. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the K2M Fenestrated Tap System?
K2M Fenestrated Tap System is a medical device that received FDA 510(k) clearance on 2016-01-05. It is manufactured by K2m. The 510(k) number is K152872.
When was K2M Fenestrated Tap System approved by the FDA?
K2M Fenestrated Tap System received FDA 510(k) clearance on 2016-01-05, under approval number K152872.
What company makes K2M Fenestrated Tap System?
K2M Fenestrated Tap System is manufactured by K2m.
What is the FDA product code for K2M Fenestrated Tap System?
The FDA product code for K2M Fenestrated Tap System is KNW.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.