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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 K203673
Device Name MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp St.
Memphis,  TN  83118
Correspondent Contact Chris Lussier
Regulation Number888.3070
Classification Product Code
PQC  
Date Received12/16/2020
Decision Date 04/06/2021
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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