FDA 510(k) Application Details - K051844

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish   More FDA Info for this Device
510(K) Number	K051844
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Applicant	PORTLAND ORTHOPAEDICS PTY. LTD. PO BOX 560 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	ELAINE DUNCAN Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	MAY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2005
Decision Date	10/07/2005
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