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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K082332
Device Name NUVASIVE SPHERX SYSTEM
Applicant
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact LAETITIA COUSIN
Correspondent
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact LAETITIA COUSIN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received08/14/2008
Decision Date 10/10/2008
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
Recalls CDRH Recalls
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