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510(k) K213104

Auxilock Titanium Screw-In Suture Anchor by Auxein Medical Private Limited — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
September 24, 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

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  • K213059 — Tibia and Fibula System (January 27, 2023)
  • K213110 — AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw- (December 16, 2022)
  • 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)
  • 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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  • 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)