Avinent Surgical Tray— 510(k) K191566

Name: FDA 510(k) clearance K191566
Creator: U.S. Food and Drug Administration
Published: 2020-03-06

Substantially Equivalent

Avinent Implant System S.L.U.

FDA 510(k) clearance K191566 for Avinent Surgical Tray, Substantially Equivalent on 2020-03-06. Applicant: Avinent Implant System S.L.U.. Device class: 2.

Clearance details

Applicant: Avinent Implant System S.L.U.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2019-06-13
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santpedor, ES

Download summary PDF View on FDA.gov ↗

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