510(k) K915448

CORTICAL BONE SCREW by Dow Corning Wright — Product Code HWC

K915448 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "CORTICAL BONE SCREW". The FDA issued a decision of Substantially Equivalent on February 28, 1992. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Dow Corning Wright has at least 10 other 510(k) clearances on record.