FDA 510(k) Application Details - K122366

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K122366
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 GENEVA 1215 CH Other 510(k) Applications for this Company
Contact	FRANK PENNESI 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	08/06/2012
Decision Date	10/04/2012
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