E-POLY TIBIAL BEARINGS


Device Classification Name

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

510(k) Number K080528
Device Name E-POLY TIBIAL BEARINGS
Applicant
BIOMET ORTHOPEDICS, INC.
56 east bell dr.
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact melissa steinwedel
Correspondent
BIOMET ORTHOPEDICS, INC.
56 east bell dr.
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact melissa steinwedel
Regulation Number 888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   MBV   OIY  
Date Received 02/26/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No