FDA 510(k) Application Details - K042635

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K042635
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	K2M, LLC 751 MILLER DRIVE SE, SUITE F1 LEESBURG, VA 20175 US Other 510(k) Applications for this Company
Contact	RICHARD W WOODS 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	09/27/2004
Decision Date	01/10/2005
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