FDA 510(k) Application Details - K052201

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K052201
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	ELLEN A YARNALL Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2005
Decision Date	11/10/2005
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