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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 K072339
Device Name NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
Applicant
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO,  CA  92121
Applicant Contact LAETITIA COUSIN
Correspondent
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO,  CA  92121
Correspondent Contact LAETITIA COUSIN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/20/2007
Decision Date 10/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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