VANGUARD ASYMMETRICAL PATELLAR COMPONENT


Device Classification Name

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

510(k) Number K110362
Device Name VANGUARD ASYMMETRICAL PATELLAR COMPONENT
Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact tamara west
Correspondent
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact tamara west
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 02/08/2011
Decision Date 02/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No