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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
510(k) Number K172833
Device Name E-XPE Acetabular Components and U-Motion II Acetabular 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
OQI  
Subsequent Product Codes
JDI   KWY   LWJ   LZO   MEH  
Date Received09/19/2017
Decision Date 06/12/2018
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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