510(k) K201831

CONFIDENCE Spinal Cement System by Depuy Spine, Inc. — Product Code NDN

K201831 is an FDA 510(k) premarket notification submitted by Depuy Spine, Inc. for the device "CONFIDENCE Spinal Cement System". The FDA issued a decision of Substantially Equivalent on August 31, 2020. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Depuy Spine, Inc. has at least 10 other 510(k) clearances on record.