Trigon Trigon HA Stand-Alone Wedge Fixation System— 510(k) K234116

Name: FDA 510(k) clearance K234116
Creator: U.S. Food and Drug Administration
Published: 2024-01-26

Substantially Equivalent

Nvision Biomedical Technologies

FDA 510(k) clearance K234116 for Trigon Trigon HA Stand-Alone Wedge Fixation System, Substantially Equivalent on 2024-01-26. Applicant: Nvision Biomedical Technologies. Device class: 2.

Clearance details

Applicant: Nvision Biomedical Technologies
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2023-12-27
Decision date: 2024-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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