ARTHREX BIOWIRE— 510(k) K091018

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K091018 for ARTHREX BIOWIRE, Substantially Equivalent on 2010-07-30. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code GAS
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2009-04-09
Decision date: 2010-07-30
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.