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FDA 510(k) Application Details - K203076
Device Classification Name
More FDA Info for this Device
510(K) Number
K203076
Device Name
Mecta-C Stand Alone Extension
Applicant
Medacta International SA
Strada Regina
Castel San Pietro CH-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
OVE
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Date Received
10/13/2020
Decision Date
11/06/2020
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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