Our certifications
DiviTum® TKa has received a FDA 510(k) clearance in the US
US Food and Drug Administration. July 2022 510(K) Clearances. US FDA website. Published July 29, 2022.
Biovica’s development, production, and distribution facility is certified according to ISO 13485:2016.
Medical Device Single Audit Program (MDSAP) U.S. certificate
Biovica’s laboratory in San Diego, CA has received CLIA certification on January 13, 2023.