FDA 510(k) Application Details - K132732

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K132732
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, STE 123 ELK GROVE VILLAGE, IL 60007 US Other 510(k) Applications for this Company
Contact	JOHN KUCZYNSKI Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2013
Decision Date	07/18/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review