FDA 510(k) Application Details - K061385

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K061385
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 SAN ANTONIO, TX 78245 US Other 510(k) Applications for this Company
Contact	W. CASEY FOX Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2006
Decision Date	05/30/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review