FDA 510(k) Application Details - K955173

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K955173
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	OSTEOTECH, INC. 51 JAMES WAY EATONTOWN, NJ 07724 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER W TALBOT 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	11/13/1995
Decision Date	02/09/1996
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