FDA 510(k) Application Details - K040601

Device Classification Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K040601
Device Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	GARY MILLER Other 510(k) Applications for this Contact
Regulation Number	888.3310   More FDA Info for this Regulation Number
Classification Product Code	KWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2004
Decision Date	10/04/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review