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510(k) K232169

FITBONE® Transport and Lengthening System by Orthofix Srl — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2024
Date Received
July 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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