FDA 510(k) Application Details - K210207

Device Classification Name	More FDA Info for this Device
510(K) Number	K210207
Device Name	Humeral Eccentric Reverse Metaphysis
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	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2021
Decision Date	03/26/2021
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