VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS


Device Classification Name

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

510(k) Number K080204
Device Name VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

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

Correspodent Contact gary baker
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 01/28/2008
Decision Date 03/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No