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510(k) K213059

Tibia and Fibula System by Auxein Medical Private Limited — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2023
Date Received
September 22, 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

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  • K213018 — Auxilock GFS Mini, GFS II Large, and GFS Ultimate (November 18, 2022)
  • K213108 — Humerus & Ulna System (November 4, 2022)
  • K213014 — Varixis Elbow System (October 3, 2022)
  • K213109 — Auxilock Draw Tight Suture-Based Anchor (August 22, 2022)
  • K213104 — Auxilock Titanium Screw-In Suture Anchor (July 29, 2022)
  • K211324 — 2.4mm Distal Radius System (March 14, 2022)
  • K210792 — Auxein Nailing System (August 25, 2021)
  • K203029 — Auxilock Titanium Interference Screw (August 20, 2021)

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  • 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)