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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 interlaminal
510(k) Number K073278
Device Name SPINOUS PROCESS 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 Number888.3050
Classification Product Code
KWP  
Date Received11/21/2007
Decision Date 03/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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