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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 K172676
Device Name NuVasive® Modulus-C Interbody System
Applicant
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Marysa E. Loustalot
Correspondent
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Cynthia Adams
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/05/2017
Decision Date 12/14/2017
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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