I.T.S. EXTREMITY FIXATION SYSTEMS— 510(k) K131722

Substantially Equivalent

I.T.S. GmbH

FDA 510(k) clearance K131722 for I.T.S. EXTREMITY FIXATION SYSTEMS, Substantially Equivalent on 2013-08-07. Applicant: I.T.S. GmbH.

Clearance details

Applicant: I.T.S. GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2013-06-12
Decision date: 2013-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.