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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 K141988
Device Name M.U.S.T PEDICLE SCREW SYSTEM
Applicant
Medacta International
1556 W. Carroll Ave.
Chicago,  IL  60607
Applicant Contact ADAM GROSS
Correspondent
Medacta International
1556 W. Carroll Ave.
Chicago,  IL  60607
Correspondent Contact ADAM GROSS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received07/22/2014
Decision Date 08/19/2014
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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