AEQUALIS FX2— 510(k) K141345

Substantially Equivalent

Tornier S.A.S.

FDA 510(k) clearance K141345 for AEQUALIS FX2, Substantially Equivalent on 2014-11-18. Applicant: Tornier S.A.S..

Clearance details

Applicant: Tornier S.A.S.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2014-05-22
Decision date: 2014-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montbonnot-Saint-Martin, 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.