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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, porous uncemented
510(k) Number K163193
Device Name UTF Stem, reduced, #0, #00
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 Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received11/15/2016
Decision Date 06/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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