BROOKER TIBIA NAILS


codes

Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K002057
Device Name BROOKER TIBIA NAILS
Original Applicant
BIOMET ORTHOPEDICS, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact patricia sandborn beres
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 07/06/2000
Decision Date 10/04/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No