SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS— 510(k) K130533

Substantially Equivalent

Tornier S.A.S.

FDA 510(k) clearance K130533 for SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS, Substantially Equivalent on 2013-05-17. Applicant: Tornier S.A.S..

Clearance details

Applicant: Tornier S.A.S.
Product code: 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

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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.