FDA 510(k) Application Details - K965221

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K965221
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	SURGICRAFT LTD. 16 THE OAKS, CLEWS ROAD REDDITCH, WORCESTERSHIRE B98 7ST GB Other 510(k) Applications for this Company
Contact	PETER DINES 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	12/31/1996
Decision Date	08/07/1997
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