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FDA 510(k) Application Details - K212030
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
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510(K) Number
K212030
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Flower Orthopedics Corporation DBA Conventus Flower
100 Witmer Road
Horsham, PA 19044 US
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Contact
Amanda Pentecost
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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
06/29/2021
Decision Date
07/23/2021
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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