FDA 510(k) Application Details - K122622

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K122622
Device Name	Spinal Vertebral Body Replacement Device
Applicant	LUCERO MEDICAL, LLC 33490 PIN OAK PARKWAY AVON LAKE, OH 44012 US Other 510(k) Applications for this Company
Contact	JENNIFER PALINCHIK 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	08/28/2012
Decision Date	09/19/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review