FDA 510(k) Application Details - K033844

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K033844
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SYNTHES (USA) 1230 WILSON DRIVE WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	SUSAN LEWANDOWSKI 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	12/11/2003
Decision Date	02/05/2004
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