FDA 510(k) Application Details - K191423

Device Classification Name	More FDA Info for this Device
510(K) Number	K191423
Device Name	Normandy VBR System
Applicant	Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 US Other 510(k) Applications for this Company
Contact	Frankie Cummins Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2019
Decision Date	08/06/2019
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