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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, Cemented
510(k) Number K121055
Device Name METS MODULAR TOTAL FEMUR
Applicant
Stanmore Implants Worldwide , Ltd.
690 Canton St., Suite 302
Canton,  MA  02090
Applicant Contact NANCY C MACDONALD
Correspondent
Stanmore Implants Worldwide , Ltd.
690 Canton St., Suite 302
Canton,  MA  02090
Correspondent Contact NANCY C MACDONALD
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
KRO  
Date Received04/06/2012
Decision Date 09/19/2012
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
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