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FDA 510(k) Application Details - K193175
Device Classification Name
More FDA Info for this Device
510(K) Number
K193175
Device Name
Lateralized Glenosphere
Applicant
Medacta Inernational SA
Strada Regina
Castel San Pietro cH-6874 CH
Other 510(k) Applications for this Company
Contact
Stefano Baj
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Regulation Number
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Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2019
Decision Date
08/11/2020
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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