Trigon PEEK HA Wedges— 510(k) K243231

Name: FDA 510(k) clearance K243231
Creator: U.S. Food and Drug Administration
Published: 2024-11-08

Substantially Equivalent

Nvision Biomedical Technologies

FDA 510(k) clearance K243231 for Trigon PEEK HA Wedges, Substantially Equivalent on 2024-11-08. 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: 2024-10-09
Decision date: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.