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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 K905613
Device Name MTS KNEE SYSTEM
Applicant
T & R Mfg., Inc.
P.O. Box 33
Red Rock,  TX  78662
Applicant Contact SANDOR TURANYI
Correspondent
T & R Mfg., Inc.
P.O. Box 33
Red Rock,  TX  78662
Correspondent Contact SANDOR TURANYI
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/14/1990
Decision Date 06/24/1991
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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