510(k) K232267

Precice Max System by Nuvasive Specialized Orthopedics, Incorporated — Product Code HSB

K232267 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Incorporated for the device "Precice Max System". The FDA issued a decision of Substantially Equivalent on December 15, 2023. 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, Incorporated has at least 3 other 510(k) clearances on record.