GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD— 510(k) K992065

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K992065 for GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD, Substantially Equivalent on 1999-07-12. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 1999-06-18
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.