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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K922486
Device Name DANEK TISSUE CUTTING AND REMOVAL SYSTEM
Applicant
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Applicant Contact BAILEY LIPSCOMB
Correspondent
Sofamor Danek Mfg., Inc.
3092 Directors Row
Memphis,  TN  38131
Correspondent Contact BAILEY LIPSCOMB
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/27/1992
Decision Date 10/12/1993
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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