Arthrex Univers Revers Monoblock Stem Size 4/33— 510(k) K230366

Name: FDA 510(k) clearance K230366
Creator: U.S. Food and Drug Administration
Published: 2023-04-10

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K230366 for Arthrex Univers Revers Monoblock Stem Size 4/33, Substantially Equivalent on 2023-04-10. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2023-02-10
Decision date: 2023-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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