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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K924323
Device Name THE UNIVERSAL BONE CEMENT RESISTOR
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 Number888.3350
Classification Product Code
JDI  
Date Received08/27/1992
Decision Date 02/12/1993
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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