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510(k) K250559

GMReis Fibula Nail System by Gm Dos Reis Industria E Comercio — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2025
Date Received
February 25, 2025
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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