FIXED BEARING UNI COMPONENT


Device Classification Name

prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer

510(k) Number K021621
Device Name FIXED BEARING UNI COMPONENT
Original Applicant
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact dalene t binkly
Regulation Number 888.3530
Classification Product Code
HRY  
Date Received 05/16/2002
Decision Date 06/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No