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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K161060.

When did Arthrex iBalance UKA System Vitamin E Tibial Bearing receive FDA 510(k) clearance?

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

Who is the listed applicant for Arthrex iBalance UKA System Vitamin E Tibial Bearing?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.

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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