FDA 510(k) Application Details - K043100

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K043100
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	BIOMET, INC. 56 EAST BELL DR. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	GARY BAKER Other 510(k) Applications for this Contact
Regulation Number	888.3670   More FDA Info for this Regulation Number
Classification Product Code	MBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2004
Decision Date	02/17/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review