510(k) K230623

KITE Distal Fibula Kit by Intrauma S.P.A — Product Code HRS

K230623 is an FDA 510(k) premarket notification submitted by Intrauma S.P.A for the device "KITE Distal Fibula Kit". The FDA issued a decision of Substantially Equivalent on Sep 1, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Intrauma S.P.A has at least 2 other 510(k) clearances on record.