FDA 510(k) Application Details - K032641

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate   More FDA Info for this Device
510(K) Number	K032641
Device Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant	PORTLAND ORTHOPAEDICS PTY. LTD. 3/44 MCCAULEY ST. MATRAVILLE NSW 2036 AU Other 510(k) Applications for this Company
Contact	DAVID SEKEL Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	MEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2003
Decision Date	01/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review