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510(k) K213018

Auxilock GFS Mini, GFS II Large, and GFS Ultimate by Auxein Medical Private Limited — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2022
Date Received
September 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Auxein Medical Private Limited

  • K221787 — Auxein's DHS/DCS Plate System (November 30, 2023)
  • K213059 — Tibia and Fibula System (January 27, 2023)
  • K213110 — AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw- (December 16, 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)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)