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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 K962553
Device Name EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
Applicant
Biodynamic Technologies, Inc.
East Newport Center Dr.
Deerfield Beach,  FL  33442
Applicant Contact DANNY HODGEMAN
Correspondent
Biodynamic Technologies, Inc.
East Newport Center Dr.
Deerfield Beach,  FL  33442
Correspondent Contact DANNY HODGEMAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/01/1996
Decision Date 08/28/1996
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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