FDA 510(k) Application Details - K991197

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K991197
Device Name	Screw, Fixation, Bone
Applicant	VILEX, INC. 1801 RT. 51, BUILDING 10 JEFFERSON HILLS, PA 15025-0724 US Other 510(k) Applications for this Company
Contact	ABRAHIM LAVI Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1999
Decision Date	04/26/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review