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FDA 510(k) Application Details - K221115
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K221115
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
Flow-FX, LLC
9301 West 191st Street
Mokena, IL 60448 US
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Contact
Patrick J. Sweeney
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2022
Decision Date
05/13/2022
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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