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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 K925812
Device Name TITANIUM SONGER CABLE SYSTEM
Applicant
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received11/12/1992
Decision Date 03/24/1993
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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