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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K140900
Device Name PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
Applicant
Stanmore Worldwide Implants , Ltd.
10 Cordage Rd. Park Cir., Suite 200
Plymouth,  MA  02360
Applicant Contact SAMANTHA SHELLEY
Correspondent
Stanmore Worldwide Implants , Ltd.
210 Centennial Ave.
Centennial Park
Elstree,  GB WD6 3SJ
Correspondent Contact Dan Clarke
Regulation Number888.3510
Classification Product Code
KRO  
Date Received04/08/2014
Decision Date 02/12/2015
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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