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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(k) Number K102547
Device Name COROENT INTERLOCK SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Applicant Contact Sheila Bruschi
Correspondent
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Correspondent Contact Sheila Bruschi
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/03/2010
Decision Date 02/07/2011
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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