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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K132704
Device Name DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
Applicant
BIOMET
56 EAST BELL DR.
P.O BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SUZANA OTANO
Correspondent
BIOMET
56 EAST BELL DR.
P.O BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SUZANA OTANO
Regulation Number888.3030
Classification Product Code
LXT  
Date Received08/29/2013
Decision Date 10/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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