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510(k) K201147

Elos® Intramedullary Nailing System by Intrauma S.P.A — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2021
Date Received
April 29, 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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