FDA 510(k) Application Details - K001271

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component   More FDA Info for this Device
510(K) Number	K001271
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant	BIOMET, INC. 56 EAST BELL DR. WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	MARY VERSTYNEN Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2000
Decision Date	07/14/2000
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