FDA 510(k) Application Details - K181921

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K181921
Device Name	Spinal Vertebral Body Replacement Device
Applicant	ulrich medical USA 18221 Edison Avenue Chesterfield, MO 63005 US Other 510(k) Applications for this Company
Contact	Hans Stover Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2018
Decision Date	11/16/2018
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