AEQUALIS PRESS-FIT SHOULDER PROSTHESIS— 510(k) K011942

Substantially Equivalent

Tornier

FDA 510(k) clearance K011942 for AEQUALIS PRESS-FIT SHOULDER PROSTHESIS, Substantially Equivalent on 2001-07-13. Applicant: Tornier.

Clearance details

Applicant: Tornier
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 2001-06-21
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Ismier, 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.