K130533

Substantially Equivalent

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

Applicant: Tornier S.A.S.
Product code: HSN
Advisory panel: Orthopedic
Date received: 2013-03-01
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Montbonnot-Saint-Martin, FR

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.