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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 Interlaminal
510(k) Number K934582
Device Name GDLH VARIABLE ANGLE CONNECTOR
Applicant
Danek Group, Inc.
3092 Directors Row
Memphis,  TN  38131
Applicant Contact RICHARD W TREHARNE, PH.D.
Correspondent
Danek Group, Inc.
3092 Directors Row
Memphis,  TN  38131
Correspondent Contact RICHARD W TREHARNE, PH.D.
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/23/1993
Decision Date 06/21/1994
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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