FDA 510(k) Application Details - K100858

Device Classification Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K100858
Device Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant	LIMA-LTO S.P.A. PO BOX 696 WINONA LAKE, IN 46590 US Other 510(k) Applications for this Company
Contact	CHERYL HASTINGS Other 510(k) Applications for this Contact
Regulation Number	888.3650   More FDA Info for this Regulation Number
Classification Product Code	KWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2010
Decision Date	12/10/2010
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