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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K962987
Device Name EZ-FIX SMALL CANNULATED SCREW SYSTEM
Applicant
Biodynamic Technologies, Inc.
1425 E. Newport Center Dr.
Deerfield Beach,  FL  33442
Applicant Contact DANNY HODGEMAN
Correspondent
Biodynamic Technologies, Inc.
1425 E. Newport Center Dr.
Deerfield Beach,  FL  33442
Correspondent Contact DANNY HODGEMAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/01/1996
Decision Date 11/04/1996
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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