510(k) K261651

Precice™ Max System and Precice™ Ankle Salvage System by NuVasive Specialized Orthopedics — Product Code HSB

K261651 is an FDA 510(k) premarket notification submitted by NuVasive Specialized Orthopedics for the device "Precice™ Max System and Precice™ Ankle Salvage System". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. NuVasive Specialized Orthopedics has at least 10 other 510(k) clearances on record.