Home / 510(k) Clearances / K202806

510(k) K202806

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) by Osteonic Co., Ltd. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2021
Date Received
September 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
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)
  • K231322 — Fix2Lock(PEEK Self Punching) (June 7, 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)

Other clearances for product code MAI

  • K254055 — OSSIOfiber® Suture Anchor (February 24, 2026)
  • K251680 — Biosteon® Screw (February 17, 2026)
  • K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit (October 15, 2025)
  • K252022 — OSSIOfiber® Interference Screw (August 19, 2025)
  • K251309 — OSSIOfiber® Suture Anchor (May 27, 2025)
  • K250544 — Knotilus+ Biocomposite Knotless Anchor (May 23, 2025)
  • K250528 — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (May 21, 2025)
  • K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm (April 3, 2025)
  • K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (March 14, 2025)
  • K243790 — GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (February 5, 2025)