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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K010901
Device Name FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
Applicant
Disc-O-Tech Medical Technologies, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Disc-O-Tech Medical Technologies, Ltd.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/26/2001
Decision Date 06/19/2001
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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