FDA 510(k) Application Details - K221049

Device Classification Name	More FDA Info for this Device
510(K) Number	K221049
Device Name	Zavation VariSync Plate System and VariSync Spacer System
Applicant	Zavation Medical Products, LLC 220 Lakeland Parkway Flowood, MS 39232 US Other 510(k) Applications for this Company
Contact	Katie Motley Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2022
Decision Date	08/12/2022
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