EXPANDABLE KNEE


Device Classification Name

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

510(k) Number K020381
Device Name EXPANDABLE KNEE
Original Applicant
BIOMET ORTHOPEDICS, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact patricia sandborn beres
Regulation Number 888.3510
Classification Product Code
KRO  
Date Received 02/05/2002
Decision Date 05/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No