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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, semi-constrained, cemented, metal/polymer
510(k) Number K032052
Device Name UC-PLUS SOLUTION UNICONDYLAR 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 Number888.3530
Classification Product Code
HRY  
Date Received07/02/2003
Decision Date 07/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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