Trigon HA Stand-Alone Wedge Fixation System— 510(k) K203445

Name: FDA 510(k) clearance K203445
Creator: U.S. Food and Drug Administration
Published: 2020-12-21

Substantially Equivalent

Nvision Biomedical Technologies, Inc.

FDA 510(k) clearance K203445 for Trigon HA Stand-Alone Wedge Fixation System, Substantially Equivalent on 2020-12-21. Applicant: Nvision Biomedical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Nvision Biomedical Technologies, Inc.
Product code: Code PLF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2020-11-23
Decision date: 2020-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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