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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K923242
Device Name CROSSLINK AXIAL AND OFFSET PLATES
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 Number888.3060
Classification Product Code
KWQ  
Date Received07/02/1992
Decision Date 05/19/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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