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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, threaded
510(k) Number K120871
Device Name SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis,  TN  38116
Original Contact gino rouss
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Codes
KTT   LXT   OSN  
Date Received03/22/2012
Decision Date 06/07/2012
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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