FDA 510(k) Application Details - K022218

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K022218
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	SPINAL CONCEPTS, INC. 12012 TECHNOLOGY BLVD., #100 AUSTIN, TX 78727 US Other 510(k) Applications for this Company
Contact	DAVID M HOOPER 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	07/09/2002
Decision Date	08/12/2002
Decision	SESE - SUBST EQUIV
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