FDA 510(k) Application Details - K960363

Device Classification Name	Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented   More FDA Info for this Device
510(K) Number	K960363
Device Name	Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Applicant	BIOMET, INC. AIRPORT INDUSTRIAL PARK WARSAW, IN 46581 US Other 510(k) Applications for this Company
Contact	PATRICIA S BERES Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/1996
Decision Date	02/18/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review