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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 K211330
Device Name R3 Large Head Liners
Applicant
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Applicant Contact Kayla Franklin
Correspondent
Smith & Nephew, Inc.
7135 Goodlett Farms Pkwy.
Cordova,  TN  38016
Correspondent Contact Kayla Franklin
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO   MEH  
Date Received05/03/2021
Decision Date 01/19/2022
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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