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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K911338
Device Name LIMA CEMENT RESTRICTOR
Applicant
Turnkey Intergration USA, Inc.
8021 Knue Rd., Suite 121
Indianapolis,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
Turnkey Intergration USA, Inc.
8021 Knue Rd., Suite 121
Indianapolis,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number878.3300
Classification Product Code
JDK  
Date Received03/26/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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