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510(k) K233025

Revolution External Plating System by New Standard Device Dba Metalogix — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2024
Date Received
September 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by New Standard Device Dba Metalogix

  • K181630 — Revolution External Plating System (May 29, 2019)

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