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510(k) K181113

CoLink™ Afx Plating System by In2bones USA, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2018
Date Received
April 27, 2018
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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  • K212487 — CoLink Vallux Plating System (November 18, 2021)
  • K203698 — CoLink Sfx Implant System (May 4, 2021)
  • K210060 — CoLink Mfx Implant System (March 12, 2021)

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