ACUMED ANATOMIC RADIAL HEAD SYSTEM— 510(k) K041858

Name: FDA 510(k) clearance K041858
Creator: U.S. Food and Drug Administration
Published: 2004-10-05

Substantially Equivalent

Acumed, LLC

FDA 510(k) clearance K041858 for ACUMED ANATOMIC RADIAL HEAD SYSTEM, Substantially Equivalent on 2004-10-05. Applicant: Acumed, LLC. Device class: 2.

Clearance details

Applicant: Acumed, LLC
Product code: Code KWI
Device class: Class 2
Regulation: 21 CFR 888.3170
Advisory panel: Orthopedic
Date received: 2004-07-09
Decision date: 2004-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsboro, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.