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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
510(k) Number K031919
Device Name EBI XFIX DFS SYSTEM
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact PETER ALLAN
Correspondent
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact PETER ALLAN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/23/2003
Decision Date 09/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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