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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K915259
Device Name FX-CABLELOK SYSTEM, MODIFICATION
Applicant
Biodynamic Technologies, Inc.
727 Twenty-Third St. S.
Arlington,  VA  22202
Applicant Contact ANDREW E TAYLOR
Correspondent
Biodynamic Technologies, Inc.
727 Twenty-Third St. S.
Arlington,  VA  22202
Correspondent Contact ANDREW E TAYLOR
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received11/19/1991
Decision Date 02/07/1992
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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