510(k) K220234

Precice Intramedullary Limb Lengthening System by Nuvasive Specialized Orthopedics, Inc. — Product Code HSB

K220234 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Inc. for the device "Precice Intramedullary Limb Lengthening System". The FDA issued a decision of Substantially Equivalent on March 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, Inc. has at least 10 other 510(k) clearances on record.