K161742

Substantially Equivalent

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

Applicant: Tornier, Inc.
Product code: PHX
Advisory panel: Orthopedic
Date received: 2016-06-24
Decision date: 2016-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, MN, US

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.