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FDA 510(k)

Arthrex iBalance BiCompartmental Arthroplasty System

K-Number: K160461 · 2016-04-12

ApplicantArthrex, Inc.
Decision Date2016-04-12
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex iBalance BiCompartmental Arthroplasty 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 2016-04-12 under 510(k) number K160461. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex iBalance BiCompartmental Arthroplasty System?

Arthrex iBalance BiCompartmental Arthroplasty System is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Arthrex, Inc.. The 510(k) number is K160461.

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

Arthrex iBalance BiCompartmental Arthroplasty System received FDA 510(k) clearance on 2016-04-12, under 510(k) number K160461.

Who is the listed applicant for Arthrex iBalance BiCompartmental Arthroplasty 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 BiCompartmental Arthroplasty System?

The FDA product code for Arthrex iBalance BiCompartmental Arthroplasty System is KRR.

Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: KRR)

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.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, 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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