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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K163441
Device Name Locking Cage, Full XPE Cup
Applicant
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Applicant Contact GIMPEL CHIEN
Correspondent
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu,  TW 300
Correspondent Contact GIMPEL CHIEN
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
JDI  
Date Received12/08/2016
Decision Date 08/25/2017
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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