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 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	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