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FDA 510(k) Application Details - K161264
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K161264
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
SMITH & NEPHEW, INC.
1450 E. BROOKS ROAD
MEMPHIS, TN 38116 US
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Contact
ALLISON CHAN
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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
05/05/2016
Decision Date
11/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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