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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 K010437
Device Name MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
Applicant
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact PATRICIA FLOOD
Correspondent
Ebi, L.P.
399 Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact PATRICIA FLOOD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/13/2001
Decision Date 03/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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