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510(k) K223226

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2022
Date Received
October 18, 2022
Clearance Type
Special
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.

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Other clearances for product code PLF

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  • 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)
  • K220197 — Trigon HA Wedge Fixation System (February 23, 2022)
  • K201314 — Restor3d Utility Wedge (June 17, 2021)
  • K203445 — Trigon HA Stand-Alone Wedge Fixation System (December 21, 2020)