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FDA 510(k)

Arthrex iBalance TKA System

K-Number: K153586 · 2016-02-19

ApplicantArthrex, Inc.
Decision Date2016-02-19
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex iBalance TKA System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153586. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex iBalance TKA System?

Arthrex iBalance TKA System is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Arthrex, Inc.. The 510(k) number is K153586.

When did Arthrex iBalance TKA System receive FDA 510(k) clearance?

Arthrex iBalance TKA System received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153586.

Who is the listed applicant for Arthrex iBalance TKA System?

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 TKA System?

The FDA product code for Arthrex iBalance TKA System is MBH.

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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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