AEQUALIS SHOULDER SYSTEM— 510(k) K063081

Substantially Equivalent

Tornier

FDA 510(k) clearance K063081 for AEQUALIS SHOULDER SYSTEM, Substantially Equivalent on 2006-11-09. Applicant: Tornier.

Clearance details

Applicant: Tornier
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2006-10-10
Decision date: 2006-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Monbonnot Saint Martin, FR

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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.