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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K023667
Device Name RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
Applicant
PLUS ORTHOPEDICS
1001 OAKWOOD BLVD.
ROUND ROCK,  TX  78681 -2700
Applicant Contact J.D. WEBB
Correspondent
PLUS ORTHOPEDICS
1001 OAKWOOD BLVD.
ROUND ROCK,  TX  78681 -2700
Correspondent Contact J.D. WEBB
Regulation Number888.3510
Classification Product Code
KRO  
Date Received10/31/2002
Decision Date 12/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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