AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS— 510(k) K131231

Substantially Equivalent

Tornier S.A.S.

FDA 510(k) clearance K131231 for AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS, Substantially Equivalent on 2013-10-16. Applicant: Tornier S.A.S..

Clearance details

Applicant: Tornier S.A.S.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2013-04-30
Decision date: 2013-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montbonnot-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.