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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 K222700
Device Name Tibial baseplate, Tibial insert
Applicant
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu City,  TW 30075
Applicant Contact Lois Ho
Correspondent
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu City,  TW 30075
Correspondent Contact Lois Ho
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/07/2022
Decision Date 10/06/2022
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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