FDA 510(k) Application Details - K050390

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K050390
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	ALPHATEC/NEXMED 6110 CORTE DEL CEDRO CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	ELLEN A YARMALL 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	02/16/2005
Decision Date	03/14/2005
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