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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Ac-Powered
510(k) Number K013215
Device Name MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
Applicant
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact SEAN M CURRY
Correspondent
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact SEAN M CURRY
Regulation Number868.2775
Classification Product Code
BXM  
Date Received09/26/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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