GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD— 510(k) K984541

Name: FDA 510(k) clearance K984541
Creator: U.S. Food and Drug Administration
Published: 1999-01-14

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K984541 for GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD, Substantially Equivalent on 1999-01-14. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KWT
Device class: Class 2
Regulation: 21 CFR 888.3650
Advisory panel: Orthopedic
Date received: 1998-12-21
Decision date: 1999-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.