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510(k) K191535

CoLink® Mini Plating System by In2bones USA, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2019
Date Received
June 10, 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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  • K203698 — CoLink Sfx Implant System (May 4, 2021)
  • K210060 — CoLink Mfx Implant System (March 12, 2021)

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