DeviceClearance

K220914

Substantially Equivalent

Tornier Perform Humeral System – Fracture

Applicant
Tornier, Inc.
Product code
PHX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, MN, US
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, through . 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.