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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 K970084
Device Name LINK CERCLAGE WIRE SYSTEM
Applicant
Turnkey Intergration USA, Inc.
962 S. Tamiami Trl. Suite 203
Sarasota,  FL  34326
Applicant Contact DOUGLAS W STUART
Correspondent
Turnkey Intergration USA, Inc.
962 S. Tamiami Trl. Suite 203
Sarasota,  FL  34326
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/09/1997
Decision Date 03/13/1997
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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