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FDA 510(k) Application Details - K203673
Device Classification Name
More FDA Info for this Device
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 SA
Strada Regina
Castel San Pietro CH-6874 CH
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Contact
Stefano Baj
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2020
Decision Date
04/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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