510(k) K180150

PL8 Wrist Reconstruction Plate by Citieffe S.R.L. — Product Code HRS

K180150 is an FDA 510(k) premarket notification submitted by Citieffe S.R.L. for the device "PL8 Wrist Reconstruction Plate". The FDA issued a decision of Substantially Equivalent on August 2, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Citieffe S.R.L. has at least 10 other 510(k) clearances on record.