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510(k) K173811

TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System by In2bones Sas — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2018
Date Received
December 15, 2017
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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