510(k) K251050

Pectus Versa System by Gm Dos Reis Industria E Comercio — Product Code HRS

K251050 is an FDA 510(k) premarket notification submitted by Gm Dos Reis Industria E Comercio for the device "Pectus Versa System". The FDA issued a decision of Substantially Equivalent on Dec 19, 2025. 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 Comercio has at least 1 other 510(k) clearance on record.