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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, Cervical
510(k) Number K140003
Device Name COROENT SMALL INTERBODY SYSTEM
Applicant
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Cynthia Adams
Correspondent
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Cynthia Adams
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received01/02/2014
Decision Date 04/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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