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510(k) K202858

Flex-ThreadTM Distal Fibula Intramedullary Nail System by Conventus Orthopaedics, LLC — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2021
Date Received
September 28, 2020
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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