OsteoMed ExtremiFix Mini & Small System Tray— 510(k) K202105

Name: FDA 510(k) clearance K202105
Creator: U.S. Food and Drug Administration
Published: 2020-10-29

Substantially Equivalent

Osteomed, LLC

FDA 510(k) clearance K202105 for OsteoMed ExtremiFix Mini & Small System Tray, Substantially Equivalent on 2020-10-29. 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: 2020-07-29
Decision date: 2020-10-29
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.