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510(k) K203698

CoLink Sfx Implant System by In2bones USA, LLC — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
December 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K210060 — CoLink Mfx Implant System (March 12, 2021)
  • K201636 — Hercules Suture Anchor System (August 20, 2020)

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