OsOpia Synthetic Bone Void Filler— 510(k) K201546

Substantially Equivalent

Revisios BV

FDA 510(k) clearance K201546 for OsOpia Synthetic Bone Void Filler, Substantially Equivalent on 2020-10-02. Applicant: Revisios BV. Device class: 2.

Clearance details

Applicant: Revisios BV
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2020-06-09
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 3723 Mb Bilthoven, NL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.