PERFORM Humeral System Stem— 510(k) K201315

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K201315 for PERFORM Humeral System Stem, Substantially Equivalent on 2020-09-11. Applicant: Tornier, Inc..

Clearance details

Applicant: Tornier, Inc.
Product code: Code PAO
Advisory panel: Orthopedic
Date received: 2020-05-18
Decision date: 2020-09-11
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, 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.