FDA 510(k) Application Details - K010635

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K010635
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	MARY L VERSTYNEN 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	03/02/2001
Decision Date	08/20/2001
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