REGENEREX TIBIAL COMPONENTS


Device Classification Name

prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

510(k) Number K080361
Device Name REGENEREX TIBIAL COMPONENTS
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Applicant Contact susan alexander
Correspondent
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact susan alexander
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received 02/11/2008
Decision Date 04/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No