FDA 510(k) Application Details - K072629

Device Classification Name	Orthopedic Computer Controlled Surgical System   More FDA Info for this Device
510(K) Number	K072629
Device Name	Orthopedic Computer Controlled Surgical System
Applicant	INTEGRATED SURGICAL SYSTEMS, INC. 1433 N. MARKET BLVD., #1 SACREMENTO, CA 95834 US Other 510(k) Applications for this Company
Contact	RUSS HIBBERT Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	OJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2007
Decision Date	08/06/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review