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FDA 510(k) Application Details - K192967
Device Classification Name
More FDA Info for this Device
510(K) Number
K192967
Device Name
Medacta Shoulder System
Applicant
Medacta International, SA
Strada Regina
Castel San Pietro 6874 CH
Other 510(k) Applications for this Company
Contact
Stefano Baj
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/23/2019
Decision Date
03/25/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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