Bioretec has submitted a market authorization request for its bioresorbable RemeOs™ magnesium screw in the U.S.
Bioretec Ltd Company Announcement 5 May 2022 at 9.00 a.m. EEST INSIDE INFORMATIONBioretec Ltd, a pioneer in bioresorbable orthopedic implants, has submitted a De Novo request for market authorization in the United States for the RemeOs™ trauma screw based on bioresorbable magnesium alloy. Bioretec estimates the market authorization in the United States to be granted during the second half of 2022. The previously communicated estimate was in the first half of 2022. The De Novo request provides a registration pathway for novel medical devices for which there is no predicate