FDA 510(k) Application Details - K013657

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K013657
Device Name	Plate, Fixation, Bone
Applicant	BIOMET ORTHOPEDICS, INC. P.O. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	TRACY J BICKEL Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2001
Decision Date	12/03/2001
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