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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K152338
Device Name VERTEX(r) Reconstruction System
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Victoria Scheitlin
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Victoria Scheitlin
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received08/19/2015
Decision Date 10/28/2015
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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