AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS— 510(k) K112144

Substantially Equivalent

Tornier

FDA 510(k) clearance K112144 for AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS, Substantially Equivalent on 2012-03-13. Applicant: Tornier.

Clearance details

Applicant: Tornier
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2011-07-26
Decision date: 2012-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Monbonnot Saint Martin, FR

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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.