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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 K234048
Device Name M.U.S.T. Pedicle Screw System - Extension
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
6386 Global Dr.
Suite 101
Memphis,  TN  38141
Correspondent Contact Christopher Lussier
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   NKG  
Date Received12/21/2023
Decision Date 02/13/2024
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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