FDA 510(k) Application Details - K012278

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K012278
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	THEKEN SURGICAL,LLC 1100 NOLA AVE. BARBETON, OH 44203-3819 US Other 510(k) Applications for this Company
Contact	RANDY THEKEN 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	07/19/2001
Decision Date	10/17/2001
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