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510(k) K222423

Fixone All Suture Anchor by Aju Pharm Co., Ltd. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2023
Date Received
August 11, 2022
Clearance Type
Special
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 Aju Pharm Co., Ltd.

  • K233601 — Fixone Meniscal Repair (August 2, 2024)
  • K230892 — Fixone Biocomposite Anchor (June 9, 2023)
  • K203523 — Fixone hybrid knotless anchor (December 25, 2021)
  • K193497 — Fixone Biocomposite Interference Screw (January 5, 2021)
  • K192709 — Fixone All Suture Anchor (December 15, 2020)
  • K192484 — Fixone Biocomposite Anchor (March 11, 2020)
  • K192032 — Fixone Biocomposite Small Anchor (March 3, 2020)
  • K171299 — Fixone Biocomposite Anchor (August 24, 2017)
  • K162070 — JOINIX CANNULAR SYSTEM (March 16, 2017)

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)