FDA 510(k) Application Details - K060127

Device Classification Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K060127
Device Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Applicant	ARTHROSURFACE, INC. 28 FORGE PARKWAY FRANKLIN, MA 02038 US Other 510(k) Applications for this Company
Contact	STEVEN W EK Other 510(k) Applications for this Contact
Regulation Number	888.3540   More FDA Info for this Regulation Number
Classification Product Code	KRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2006
Decision Date	03/16/2006
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