FDA 510(k) Application Details - K041583

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K041583
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	INNOVASIS, INC. 997 EAST 3900 SOUTH SUITE 103 SALT LAKE CITY, UT 84124 US Other 510(k) Applications for this Company
Contact	BRENT A FELIX 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	06/11/2004
Decision Date	07/22/2004
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