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510(k) K251913

OsteoCentric® UnifiMI® TCS Plating System by OsteoCentric Technologies — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2025
Date Received
June 23, 2025
Clearance Type
Special
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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  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
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  • K211290 — Cannulated Fasteners and Nuts (August 3, 2021)

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