FDA 510(k) Application Details - K081381

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K081381
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	K2M, INC. 751 MILLER DR.,SE LEESBURG, VA 20175 US Other 510(k) Applications for this Company
Contact	RICHARD W WOODS Other 510(k) Applications for this Contact
Regulation Number	888.3070   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	05/16/2008
Decision Date	06/13/2008
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