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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 K043405
Device Name NUVASIVE COROENT 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
MQP  
Date Received12/10/2004
Decision Date 02/07/2005
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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