510(k) K211290

Cannulated Fasteners and Nuts by OsteoCentric Technologies — Product Code HWC

K211290 is an FDA 510(k) premarket notification submitted by OsteoCentric Technologies for the device "Cannulated Fasteners and Nuts". The FDA issued a decision of Substantially Equivalent on August 3, 2021. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. OsteoCentric Technologies has at least 10 other 510(k) clearances on record.