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FDA 510(k) Application Details - K221389
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K221389
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Medacta International S.A.
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
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/13/2022
Decision Date
06/08/2022
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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