FDA 510(k) Application Details - K051286

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K051286
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	ALPHATEC/NEXMED 6110 CORTE DEL CEDRO CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	ELLEN A YARNALL Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2005
Decision Date	06/17/2005
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