ARTHREX IBALANCE TKA SYSTEM— 510(k) K141635

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K141635 for ARTHREX IBALANCE TKA SYSTEM, Substantially Equivalent on 2014-09-03. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2014-06-19
Decision date: 2014-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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