510(k) K230397

Cut Screw - Percutaneous Compression Screw by GM Dos Reis Industria e Comercio Ltda. — Product Code HWC

K230397 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Cut Screw - Percutaneous Compression Screw". The FDA issued a decision of Substantially Equivalent on June 12, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.