Home / 510(k) Clearances / K193414

510(k) K193414

Trigon HA Stand-Alone Wedge Fixation System by Nvision Biomedical Technologies, Inc. — Product Code PLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2020
Date Received
December 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Wedge
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

Other clearances by Nvision Biomedical Technologies, Inc.

  • K253423 — ToeJack MIS Bunion System (November 18, 2025)
  • K252657 — Impact PEEK Union Nail System (September 19, 2025)
  • K250646 — Impact PEEK Union Nail System (June 11, 2025)
  • K250613 — SnapHammer Hammertoe Correction System (April 2, 2025)
  • K242896 — Caliber Intramedullary Fixation System (February 5, 2025)
  • K243231 — Trigon PEEK HA Wedges (November 8, 2024)
  • K240250 — 3D Printed PEEK Interbody System (September 17, 2024)
  • K231453 — SnapHammer Hammertoe Correction System (February 16, 2024)
  • K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System (January 26, 2024)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)

Other clearances for product code PLF

  • K252733 — ATLAS™ Expandable Osteotomy Wedge System (February 19, 2026)
  • K252254 — Osteotomy Wedge System (October 17, 2025)
  • K251791 — Auxano® Wedge Fixation System (September 25, 2025)
  • K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories (December 6, 2024)
  • K243231 — Trigon PEEK HA Wedges (November 8, 2024)
  • K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System (January 26, 2024)
  • K231496 — TITAN 3-D Wedge System (August 22, 2023)
  • K223226 — Trigon™ HA Stand-Alone Wedge Fixation System (December 1, 2022)
  • K220197 — Trigon HA Wedge Fixation System (February 23, 2022)
  • K201314 — Restor3d Utility Wedge (June 17, 2021)