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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 K000083
Device Name EBI XFIX DFS RAIL SYSTEM
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact JONAS WILF
Correspondent
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact JONAS WILF
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/12/2000
Decision Date 02/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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