OrthoGold— 510(k) K191961

Substantially Equivalent

Tissue Regeneration Technologies

FDA 510(k) clearance K191961 for OrthoGold, Substantially Equivalent on 2019-11-26. Applicant: Tissue Regeneration Technologies. Device class: 2.

Clearance details

Applicant: Tissue Regeneration Technologies
Product code: Code PZL
Device class: Class 2
Regulation: 21 CFR 878.4685
Advisory panel: General, Plastic Surgery
Date received: 2019-07-23
Decision date: 2019-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GA, 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.