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FDA 510(k) Application Details - K122170
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K122170
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
SMITH & NEPHEW, INC.
7135 Goodlett Farms Parkway
Cordova, TN 38016 US
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Contact
Bradley Heil
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
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More FDA Info for this Product Code
Date Received
07/23/2012
Decision Date
10/19/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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