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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K943986
Device Name LINK ENDO MODEL REVISION CUP
Applicant
Turnkey Intergration USA, Inc.
6060 Castleway Dr. W.
Suite 236
Indianapolis,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
Turnkey Intergration USA, Inc.
6060 Castleway Dr. W.
Suite 236
Indianapolis,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/16/1994
Decision Date 07/05/1995
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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