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510(k) K203817

Tyber Medical Anatomical Plating System by Tyber Medical, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2021
Date Received
December 29, 2020
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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  • K232693 — Tyber Medical Distal Radius Plating System (December 4, 2023)
  • K231339 — Tyber Medical Pin and Wire System (various) (July 6, 2023)

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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