Arthrex iBalance BiCompartmental Arthroplasty System— 510(k) K160461

Name: FDA 510(k) clearance K160461
Creator: U.S. Food and Drug Administration
Published: 2016-04-12

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K160461 for Arthrex iBalance BiCompartmental Arthroplasty System, Substantially Equivalent on 2016-04-12. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2016-02-19
Decision date: 2016-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.