FDA 510(k) Application Details - K063278

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented   More FDA Info for this Device
510(K) Number	K063278
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant	PORTLAND ORTHOPAEDICS LIMITED P.O. 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	888.3350   More FDA Info for this Regulation Number
Classification Product Code	JDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2006
Decision Date	01/12/2007
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