FDA 510(k) Application Details - K060412

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K060412
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant	AUSTRALIAN SURGICAL DESIGN & MANUFACTURE 2530 RIVA ROAD, SUITE 308 ANNAPOLIS, MD 21401 US Other 510(k) Applications for this Company
Contact	JAMES F LOGAN Other 510(k) Applications for this Contact
Regulation Number	888.3530   More FDA Info for this Regulation Number
Classification Product Code	HRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2006
Decision Date	05/17/2006
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