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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
Original Applicant
STANMORE IMPLANTS WORLDWIDE LTD.
690 canton street
suite 302
westwood,  MA  02090
Original 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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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