510(k) K182718

Mini and Micro Fragments Reconstruction System – GMReis by Gm Dos Reis Industria E Comerico Ltda. — Product Code HRS

K182718 is an FDA 510(k) premarket notification submitted by Gm Dos Reis Industria E Comerico Ltda. for the device "Mini and Micro Fragments Reconstruction System – GMReis". The FDA issued a decision of Substantially Equivalent on December 23, 2019. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Gm Dos Reis Industria E Comerico Ltda. has at least 2 other 510(k) clearances on record.