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510(k) K190385

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System by In2bones USA, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2019
Date Received
February 19, 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

Other clearances by In2bones USA, LLC

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  • K233089 — NeoSpan® Compression Implant System (May 24, 2024)
  • 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)

Other clearances for product code HRS

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  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)