DeviceClearance

K201315

Substantially Equivalent

PERFORM Humeral System – Stem

Applicant
Tornier, Inc.
Product code
PAO
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 PAO

product code PAO
Injury
273
Total
273

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.