510(k) K150661

ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite by Citieffe S.R.L. — Product Code JDW

K150661 is an FDA 510(k) premarket notification submitted by Citieffe S.R.L. for the device "ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite". The FDA issued a decision of Substantially Equivalent on July 7, 2015. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Citieffe S.R.L. has at least 10 other 510(k) clearances on record.