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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K931960
Device Name NUFFIELD TOTAL KNEE
Applicant
Turnkey Intergration USA, Inc.
8021 Knue Rd., Suite 121
Indianapolis,  IN  46250
Applicant Contact DOUGLAS STUART
Correspondent
Turnkey Intergration USA, Inc.
8021 Knue Rd., Suite 121
Indianapolis,  IN  46250
Correspondent Contact DOUGLAS STUART
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/21/1993
Decision Date 10/07/1994
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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