FDA 510(k) Application Details - K172323

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K172323
Device Name	Spinal Vertebral Body Replacement Device
Applicant	Omnia Medical, LLC 1000 Hampton Center Suite G Morgantown, WV 26505 US Other 510(k) Applications for this Company
Contact	Troy Schifano 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	08/01/2017
Decision Date	10/26/2017
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