510(k) K242311

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

K242311 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "EXPERT - Flexible Joint Fixation System". The FDA issued a decision of Substantially Equivalent on November 1, 2024. 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.