510(k) K250498

BPS Wrist Fracture System by Orthonovis, Inc. — Product Code HRS

K250498 is an FDA 510(k) premarket notification submitted by Orthonovis, Inc. for the device "BPS Wrist Fracture System". The FDA issued a decision of Substantially Equivalent on March 17, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthonovis, Inc. has at least 4 other 510(k) clearances on record.