FDA 510(k) Application Details - K053094

Device Classification Name	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)   More FDA Info for this Device
510(K) Number	K053094
Device Name	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Applicant	ADVANCED BIO-SURFACES, INC. 5909 BAKER ROAD, SUITE 550 MINNETONKA, MN 55345 US Other 510(k) Applications for this Company
Contact	PHILLIP B JARVI Other 510(k) Applications for this Contact
Regulation Number	888.3590   More FDA Info for this Regulation Number
Classification Product Code	HSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2005
Decision Date	02/06/2006
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