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

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..

Clearance details

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

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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.