BRIGHAM TIBIAL CEMENT PRESSURIZER— 510(k) K833675

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K833675 for BRIGHAM TIBIAL CEMENT PRESSURIZER, Substantially Equivalent on 1983-12-12. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code KIH
Advisory panel: Orthopedic
Date received: 1983-10-18
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KIH

product code KIH

Death: 3
Total: 3

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.