FDA 510(k) Application Details - K982011

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K982011
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	LYNNETTE WHITAKER 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	06/08/1998
Decision Date	08/06/1998
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