510(k) K202348

External Remote Controller ERC 4P by Nuvasive Specialized Orthopedics, Inc. — Product Code HSB

K202348 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Inc. for the device "External Remote Controller ERC 4P". The FDA issued a decision of Substantially Equivalent on December 22, 2020. 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.