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510(k) K192592

Axis Plating System by Extremity Medical, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2019
Date Received
September 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K172260 — Omni Foot Plating System (November 6, 2017)

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