FDA 510(k) Application Details - K954856

Device Classification Name	Implant, Fixation Device, Spinal   More FDA Info for this Device
510(K) Number	K954856
Device Name	Implant, Fixation Device, Spinal
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	ANGELA J SILVESTRI Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	JDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1995
Decision Date	03/08/1996
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