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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pedicle Screw Placement Guide
510(k) Number K200792
Device Name MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
Applicant
Medacta Inernational SA
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp St.
Memphis,  TN  38118
Correspondent Contact Chris Lussier
Regulation Number888.3070
Classification Product Code
PQC  
Date Received03/26/2020
Decision Date 10/05/2020
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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