OsteoMed QuickFix Hybrid MMF Sterilization Tray— 510(k) K173391

Name: FDA 510(k) clearance K173391
Creator: U.S. Food and Drug Administration
Published: 2018-05-10

Substantially Equivalent

Osteomed, LLC

FDA 510(k) clearance K173391 for OsteoMed QuickFix Hybrid MMF Sterilization Tray, Substantially Equivalent on 2018-05-10. Applicant: Osteomed, LLC. Device class: 2.

Clearance details

Applicant: Osteomed, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2017-10-30
Decision date: 2018-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.