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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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K121393
Device Name SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis,  TN  38116
Original Contact gino rouss
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
HRY   HSX   JWH   KRO   KRQ  
KRR   NPJ  
Date Received05/09/2012
Decision Date 08/07/2012
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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