BRIGHAM TOTAL ANKLE PROSTHESIS— 510(k) K803167

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K803167 for BRIGHAM TOTAL ANKLE PROSTHESIS, Substantially Equivalent on 1981-02-19. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code HSN
Advisory panel: Orthopedic
Date received: 1980-12-15
Decision date: 1981-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

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.