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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K191056
Device Name Conformity stem, cemented
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 Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWY   LZO  
Date Received04/19/2019
Decision Date 01/03/2020
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
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