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FDA 510(k) Application Details - K110552
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
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510(K) Number
K110552
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact
RYAN BORMANN
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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
02/28/2011
Decision Date
03/23/2011
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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