FDA 510(k) Application Details - K002998

Device Classification Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K002998
Device Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant	BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	TRACY J BICKE; 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	09/26/2000
Decision Date	10/06/2000
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