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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K121837
Device Name NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
Applicant
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Cynthia Adams
Correspondent
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Cynthia Adams
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/22/2012
Decision Date 07/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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