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FDA 510(k) Application Details - K203671
Device Classification Name
More FDA Info for this Device
510(K) Number
K203671
Device Name
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
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
OUR
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More FDA Info for this Product Code
Date Received
12/16/2020
Decision Date
01/13/2021
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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