Bioretec has submitted additional information requested by the FDA for US registration of RemeOs™ Trauma Screws, and the estimated approval timeline of April 2023 remains unchanged
Bioretec Ltd 3 January 2023 at 10:30 p.m. EETBioretec Ltd, a pioneer in bioresorbable orthopedic implants, has finalized the supplement for market authorization request in accordance with the De Novo registration process concerning the company's RemeOs™ trauma screw, and FDA (U.S. Food and Drug Administration) has now confirmed having received the supplement. Bioretec´s estimate for receival of the U.S. market authorization remains unchanged in April 2023. After receiving the supplement, FDA has, according to its internal