AEQUALIS REVERSED PROSTHESIS— 510(k) K061439

Substantially Equivalent

Tornier

FDA 510(k) clearance K061439 for AEQUALIS REVERSED PROSTHESIS, Substantially Equivalent on 2006-07-20. Applicant: Tornier.

Clearance details

Applicant: Tornier
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2006-05-24
Decision date: 2006-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Saint-Ismier Cedex, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.