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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 K953406
Device Name EBI X FIX DYNAFIX SYSTEM (DFS)
Applicant
Electro-Biology, Inc.
Colombia Sq.
555 Thirteenth St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Electro-Biology, Inc.
Colombia Sq.
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/20/1995
Decision Date 10/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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