OPTECURE— 510(k) K050806

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K050806 for OPTECURE, Substantially Equivalent on 2006-02-08. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2005-03-30
Decision date: 2006-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, 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.