ARTHREX BIO-TRANSFIX— 510(k) K011172

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K011172 for ARTHREX BIO-TRANSFIX, Substantially Equivalent on 2001-06-19. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MNU
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2001-04-17
Decision date: 2001-06-19
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.