510(k) K151021

OsteoMed Cannulated Screw System by Osteomed Corp. — Product Code HWC

K151021 is an FDA 510(k) premarket notification submitted by Osteomed Corp. for the device "OsteoMed Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on July 15, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Osteomed Corp. has at least 10 other 510(k) clearances on record.