FDA 510(k) Application Details - K150073

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K150073
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 US
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Contact Jeanine Redden
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 01/14/2015
Decision Date 02/10/2015
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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