OPERA CUPFLANGED ACETABULAR COMPONENTS— 510(k) K991538

Substantially Equivalent

Smith & Nephew, Inc., Orthopaedic Div.

FDA 510(k) clearance K991538 for OPERA CUPFLANGED ACETABULAR COMPONENTS, Substantially Equivalent on 1999-06-03. Applicant: Smith & Nephew, Inc., Orthopaedic Div..

Clearance details

Applicant: Smith & Nephew, Inc., Orthopaedic Div.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1999-05-03
Decision date: 1999-06-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Memphis, TN, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.