DOMED AND FINNED ACETABULAR COMPONENT— 510(k) K901328

Substantially Equivalent for Some Indications

Orthomet, Inc.

FDA 510(k) clearance K901328 for DOMED AND FINNED ACETABULAR COMPONENT, Substantially Equivalent for Some Indications on 1990-05-22. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1990-03-21
Decision date: 1990-05-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Minneapolis, MN, 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.