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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K162061
Device Name M.U.S.T. Pedicle Screw System
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Mapi USA, Inc.
2343 Alexandria Dr., Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Wheeler
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received07/26/2016
Decision Date 10/21/2016
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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