FDA 510(k) Application Details - K964404

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K964404
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	SPINAL CONCEPTS, INC. 701 BRAZOS SUITE 500 AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	ERIN MCGURK 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	11/04/1996
Decision Date	03/26/1997
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