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510(k) K241387

CoLink NeoFuse MIS Plating System (see attached parts list) by In2bones USA — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2024
Date Received
May 15, 2024
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

Other clearances by In2bones USA

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  • K220260 — Hercules Syndesmosis Implant System (March 31, 2022)
  • K212872 — Avenger Radial Head System (December 17, 2021)
  • K213069 — CoLink NeoFuse Plating System (December 13, 2021)
  • K212487 — CoLink Vallux Plating System (November 18, 2021)
  • K203698 — CoLink Sfx Implant System (May 4, 2021)
  • K210060 — CoLink Mfx Implant System (March 12, 2021)
  • K201636 — Hercules Suture Anchor System (August 20, 2020)

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