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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 K111410
Device Name NUVASIVE LONG LATERAL SPINAL SYSTEM
Applicant
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Elias Ketchum
Correspondent
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Elias Ketchum
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/19/2011
Decision Date 06/20/2011
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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