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510(k) K231322

Fix2Lock(PEEK Self Punching) by Osteonic Co., Ltd. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2023
Date Received
May 8, 2023
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 Osteonic Co., Ltd.

  • K254182 — Aster (February 26, 2026)
  • K243469 — SIGNEX (May 29, 2025)
  • K243470 — Fix2Lock (PEEK Self Punching) (December 3, 2024)
  • K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) (December 3, 2024)
  • K230546 — SIGNEX (June 11, 2024)
  • K233659 — Suture Wing (December 26, 2023)
  • K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (May 31, 2023)
  • K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu (January 27, 2022)
  • K211992 — Ortho MI System (October 15, 2021)
  • K210122 — Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (August 27, 2021)

Other clearances for product code MBI

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  • 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)