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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K032476
Device Name NUVASIVE MESH
Applicant
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact LAETITIA BERNARD
Correspondent
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact LAETITIA BERNARD
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/12/2003
Decision Date 11/13/2003
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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