FDA 510(k) Application Details - K112648

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K112648
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	MEDICAL DESIGNS, LLC 1210 W. 18TH ST. SUITE 104 SIOUX FALLS, SD 57104 US Other 510(k) Applications for this Company
Contact	KRISTI VONDRA 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	09/12/2011
Decision Date	03/13/2012
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