FDA 510(k) Application Details - K092198

Device Classification Name	Prosthesis, Hip, Femoral, Resurfacing   More FDA Info for this Device
510(K) Number	K092198
Device Name	Prosthesis, Hip, Femoral, Resurfacing
Applicant	CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 TAMPA, FL 33612 US Other 510(k) Applications for this Company
Contact	ASHLEA BOWEN Other 510(k) Applications for this Contact
Regulation Number	888.3400   More FDA Info for this Regulation Number
Classification Product Code	KXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2009
Decision Date	04/15/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review