FDA 510(k) Application Details - K081673

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K081673
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	IONICS MEDICAL CORP. 248 BIRD HAVEN LN. ETHER, NC 27247-0179 US Other 510(k) Applications for this Company
Contact	M. LAINE MASHBUM Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2008
Decision Date	11/14/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review