FDA 510(k) Application Details - K210062

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K210062
Device Name	Prosthesis, Hip, Cement Restrictor
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	878.3300   More FDA Info for this Regulation Number
Classification Product Code	JDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2021
Decision Date	04/08/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review