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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K062765
Device Name MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
Applicant
Nuvasive, Inc.
4545 Towne Centre Ct.
San Diego,  CA  92121
Applicant Contact LAETITIA COUSIN
Correspondent
Nuvasive, Inc.
4545 Towne Centre Ct.
San Diego,  CA  92121
Correspondent Contact LAETITIA COUSIN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/29/2006
Decision Date 01/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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