EXPLOR RADIAL HEAD PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K110201
Device Name EXPLOR RADIAL HEAD PLATING SYSTEM
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia s beres
Correspondent
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia s beres
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 01/24/2011
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No