FDA 510(k) Application Details - K052917

Device Classification Name	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K052917
Device Name	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. MAHWAH, NJ 07430 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	NPJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2005
Decision Date	12/27/2005
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