ULTIMA METAL-ON-METAL ACETABULAR CUP— 510(k) K001523

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K001523 for ULTIMA METAL-ON-METAL ACETABULAR CUP, Substantially Equivalent on 2000-08-10. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 2000-05-16
Decision date: 2000-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.