510(k) K230945

Forma Medical Headless Compression Screw by Forma Medical, Inc. — Product Code HWC

K230945 is an FDA 510(k) premarket notification submitted by Forma Medical, Inc. for the device "Forma Medical Headless Compression Screw". The FDA issued a decision of Substantially Equivalent on July 18, 2023. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Forma Medical, Inc. has at least 1 other 510(k) clearance on record.