510(k) K200332

EXPERT - Joint Fixation System by GM Dos Reis Industria e Comercio Ltda. — Product Code HTN

K200332 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "EXPERT - Joint Fixation System". The FDA issued a decision of Substantially Equivalent on October 29, 2020. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.