FDA 510(k) Application Details - K013042

Device Classification Name	Prosthesis, Elbow, Constrained, Cemented   More FDA Info for this Device
510(K) Number	K013042
Device Name	Prosthesis, Elbow, Constrained, Cemented
Applicant	BIOMET ORTHOPEDICS, INC. P.O. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	SARA B SHULTZ Other 510(k) Applications for this Contact
Regulation Number	888.3150   More FDA Info for this Regulation Number
Classification Product Code	JDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2001
Decision Date	10/10/2001
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