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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 K233093
Device Name Balanced Knee® System TriMax PS Plus Tibial Insert
Applicant
Ortho Development Corporation
12187 S. Business Park Drive
Draper,  UT  84020
Applicant Contact Drew Weaver
Correspondent
Ortho Development Corporation
12187 S. Business Park Drive
Draper,  UT  84020
Correspondent Contact Drew Weaver
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/26/2023
Decision Date 10/25/2023
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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