OSSEOCONDUCT— 510(k) K101718

Name: FDA 510(k) clearance K101718
Creator: U.S. Food and Drug Administration
Published: 2010-10-26

Substantially Equivalent

Steiner Laboratories Div of Steiner Healthcare, LLC

FDA 510(k) clearance K101718 for OSSEOCONDUCT, Substantially Equivalent on 2010-10-26. Applicant: Steiner Laboratories Div of Steiner Healthcare, LLC. Device class: 2.

Clearance details

Applicant: Steiner Laboratories Div of Steiner Healthcare, LLC
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-06-18
Decision date: 2010-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kapolei, HI, 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.