FDA 510(k) Application Details - K980288

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K980288
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	SPINE-TECH, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439-2029 US Other 510(k) Applications for this Company
Contact	DAVID A CANNISTRACI 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	01/26/1998
Decision Date	07/29/1998
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review