FDA 510(k) Application Details - K972516

Device Classification Name	Nail, Fixation, Bone   More FDA Info for this Device
510(K) Number	K972516
Device Name	Nail, Fixation, Bone
Applicant	SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD PAOLI, PA 19301-1222 US Other 510(k) Applications for this Company
Contact	ANGELA SILVESTRI Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/1997
Decision Date	09/04/1997
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