FDA 510(k) Application Details - K192214

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K192214
Device Name	Spinal Vertebral Body Replacement Device
Applicant	CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya 4672411 IL Other 510(k) Applications for this Company
Contact	Yael Rubin 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	08/15/2019
Decision Date	10/11/2019
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