510(k) K230527

WishBone Medical Plate and Screw System by Wishbone Medical, Inc. — Product Code HRS

K230527 is an FDA 510(k) premarket notification submitted by Wishbone Medical, Inc. for the device "WishBone Medical Plate and Screw System". The FDA issued a decision of Substantially Equivalent on March 29, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Wishbone Medical, Inc. has at least 8 other 510(k) clearances on record.