FDA 510(k) Application Details - K953777

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K953777
Device Name	Cerclage, Fixation
Applicant	SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	ANGELA J SILVESTRI Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/1995
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