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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 bone graft, thoracic
510(k) Number K150994
Device Name NuVasive CoRoent Thoracolumbar Implants
Applicant
NUVASIVE, INCORPORATED
7475 LUSK BLVD.
SAN DIEGO,  CA  92121
Applicant Contact CYNTHIA ADAMS
Correspondent
NUVASIVE, INCORPORATED
7475 LUSK BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact CYNTHIA ADAMS
Regulation Number888.3080
Classification Product Code
PHM  
Subsequent Product Codes
MAX   MQP  
Date Received04/15/2015
Decision Date 06/17/2015
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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