FDA 510(k) Application Details - K030608

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K030608
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	OSTEOIMPLANT TECHNOLOGY, INC. 11201 PEPPER RD. HUNT VALLEY, MD 21031-1201 US Other 510(k) Applications for this Company
Contact	SAM SON 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	02/26/2003
Decision Date	06/12/2003
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review