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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K061778
Device Name NUVASIVE SPHERX II 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 Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI   NKB  
Date Received06/26/2006
Decision Date 07/18/2006
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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