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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, Lumbar
510(k) Number K112561
Device Name NUVASIVE COROENT NO-PROFILE 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
OVD  
Subsequent Product Code
MAX  
Date Received09/02/2011
Decision Date 03/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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