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510(k) K241218

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2024
Date Received
May 1, 2024
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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  • K232693 — Tyber Medical Distal Radius Plating System (December 4, 2023)
  • K231339 — Tyber Medical Pin and Wire System (various) (July 6, 2023)
  • K222465 — Tyber Medical Anatomical Plating System (March 7, 2023)

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