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510(k) K213069

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2021
Date Received
September 23, 2021
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, LLC

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  • K231236 — IBS-B MIS Beveled Screw System (July 27, 2023)
  • K213698 — CoLink PCR Plating System (May 27, 2022)
  • K220260 — Hercules Syndesmosis Implant System (March 31, 2022)
  • K212872 — Avenger Radial Head System (December 17, 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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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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