FDA 510(k) Application Details - K984375

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K984375
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	OSTEONICS CORP. 59 ROUTE 17 ALLENDALE, NJ 07401-1677 US Other 510(k) Applications for this Company
Contact	MARYBETH NAUGHTON 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	12/07/1998
Decision Date	04/30/1999
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