FDA 510(k) Application Details - K061465

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K061465
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	JOHN G SPAMPINATO Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	JDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2006
Decision Date	10/05/2006
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review