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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 K173951
Device Name Legend Acetabular Liners
Applicant
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact Drew Weaver
Correspondent
Ortho Development Corporation
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact Drew Weaver
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received12/27/2017
Decision Date 05/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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