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510(k) K203445

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2020
Date Received
November 23, 2020
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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  • K223226 — Trigon™ HA Stand-Alone Wedge Fixation System (December 1, 2022)
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