OrthoGold 100— 510(k) K200926

Name: FDA 510(k) clearance K200926
Creator: U.S. Food and Drug Administration
Published: 2020-08-28

Substantially Equivalent

Tissue Regeneration Technologies, LLC

FDA 510(k) clearance K200926 for OrthoGold 100, Substantially Equivalent on 2020-08-28. Applicant: Tissue Regeneration Technologies, LLC. Device class: 2.

Clearance details

Applicant: Tissue Regeneration Technologies, LLC
Product code: Code PZL
Device class: Class 2
Regulation: 21 CFR 878.4685
Advisory panel: General, Plastic Surgery
Date received: 2020-04-07
Decision date: 2020-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GA, US

Download summary PDF View on FDA.gov ↗

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