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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 K190100
Device Name USTAR II System
Applicant
United Orthopedic Corporation
No 57, Park Ave 2, Science Park
Hsinchu,  TW 30075
Applicant Contact Lois Ho
Correspondent
United Orthopedic Corporation
No 57, Park Ave 2, Science Park
Hsinchu,  TW 30075
Correspondent Contact Lois Ho
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
KWL   LPH   LWJ  
Date Received01/22/2019
Decision Date 09/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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