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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 K152530
Device Name UCP Stem
Applicant
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2, SCIENCE PARK
HSINCHU,  TW 300
Applicant Contact KAREN HO
Correspondent
UNITED ORTHOPEDIC CORPORATION
NO 57, PARK AVE 2, SCIENCE PARK
HSINCHU,  TW 300
Correspondent Contact KAREN HO
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWY   LWJ  
Date Received09/03/2015
Decision Date 03/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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