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FDA 510(k)

Arthrex iBalance UKA System Vitamin E Tibial Bearing

K-Number: K161060 · 2016-12-15

ApplicantArthrex, Inc.
Decision Date2016-12-15
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex iBalance UKA System Vitamin E Tibial Bearing is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-12-15 under approval number K161060. 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 Arthrex iBalance UKA System Vitamin E Tibial Bearing?

Arthrex iBalance UKA System Vitamin E Tibial Bearing is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Arthrex, Inc.. The 510(k) number is K161060.

When was Arthrex iBalance UKA System Vitamin E Tibial Bearing approved by the FDA?

Arthrex iBalance UKA System Vitamin E Tibial Bearing received FDA 510(k) clearance on 2016-12-15, under approval number K161060.

What company makes Arthrex iBalance UKA System Vitamin E Tibial Bearing?

Arthrex iBalance UKA System Vitamin E Tibial Bearing is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex iBalance UKA System Vitamin E Tibial Bearing?

The FDA product code for Arthrex iBalance UKA System Vitamin E Tibial Bearing is HSX.

Related Clinical Trials

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Other Devices by Arthrex, Inc.

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Related Devices (Code: 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.

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