FDA 510(k) Application Details - K212512

Device Classification Name	More FDA Info for this Device
510(K) Number	K212512
Device Name	G7« Vivacit-E« Freedom« Constrained Liner
Applicant	Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 US Other 510(k) Applications for this Company
Contact	Romil Sheth Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2021
Decision Date	04/28/2022
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