FDA 510(k) Application Details - K041382

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K041382
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	OSTEOBIOLOGICS, INC. 12500 NETWORK SUITE 112 SAN ANTONIO, TX 78249 US Other 510(k) Applications for this Company
Contact	GABRIELE G NIEDERAUER, PH.D. 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	05/25/2004
Decision Date	06/17/2005
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