510(k) K013215

MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM by Nuvasive, Inc. — Product Code BXM

K013215 is an FDA 510(k) premarket notification submitted by Nuvasive, Inc. for the device "MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 2001. The device falls under product code BXM (Stimulator, Nerve, Ac-Powered), a Class II device regulated under 21 CFR 868.2775. Nuvasive, Inc. has at least 10 other 510(k) clearances on record.