510(k) K213489

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate by Wishbone Medical, Inc. — Product Code HRS

K213489 is an FDA 510(k) premarket notification submitted by Wishbone Medical, Inc. for the device "Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate". The FDA issued a decision of Substantially Equivalent on January 27, 2022. 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.