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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 K120992
Device Name METS SMILES TOTAL KNEE REPLACEMENT
Applicant
STANMORE IMPLANTS WORLDWIDE LTD
690 CANTON STREET
SUITE 302
WESTWOOD,  MA  02090
Applicant Contact NANCY C MACDONALD
Correspondent
STANMORE IMPLANTS WORLDWIDE LTD
690 CANTON STREET
SUITE 302
WESTWOOD,  MA  02090
Correspondent Contact NANCY C MACDONALD
Regulation Number888.3510
Classification Product Code
KRO  
Date Received04/02/2012
Decision Date 09/05/2012
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
Recalls CDRH Recalls
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