FDA 510(k) Application Details - K081293

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K081293
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant	AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	LISA M BOYLE Other 510(k) Applications for this Contact
Regulation Number	888.3530   More FDA Info for this Regulation Number
Classification Product Code	HRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2008
Decision Date	09/22/2008
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