FDA 510(k) Application Details - K192145

Device Classification Name	More FDA Info for this Device
510(K) Number	K192145
Device Name	Galileo Vertebral Body Replacement Device
Applicant	Bright Spine 799 NE 71st Street Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Robert Simonson 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	08/08/2019
Decision Date	04/21/2020
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