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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 K183312
Device Name Conformity Stem
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 Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received11/29/2018
Decision Date 08/08/2019
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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