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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 K031401
Device Name FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
Applicant
Disco-O-Tech Medical Technologies, Ltd.
3 Hasadnoat St.
Herzlia,  IL 46728
Applicant Contact YAEL RUBIN
Correspondent
Disco-O-Tech Medical Technologies, Ltd.
3 Hasadnoat St.
Herzlia,  IL 46728
Correspondent Contact YAEL RUBIN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/05/2003
Decision Date 08/06/2003
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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