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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K031280
Device Name ULTRA-DRIVE 3
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.4580
Classification Product Code
JDX  
Date Received04/22/2003
Decision Date 09/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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