REPICCI LOCKED KEEL TIBIAL BEARING


Device Classification Name

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

510(k) Number K030446
Device Name REPICCI LOCKED KEEL TIBIAL BEARING
Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Applicant Contact tracy j bickel
Correspondent
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Correspodent Contact tracy j bickel
Regulation Number 888.3530
Classification Product Code
HRY  
Date Received 02/11/2003
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No