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510(k) K201149

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
April 29, 2020
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)
  • 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)

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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)
  • K251732 — Wrist Fracture System (February 12, 2026)
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