ADDPLUS— 510(k) K090841

Substantially Equivalent

Ulrich GmbH & Co. KG

FDA 510(k) clearance K090841 for ADDPLUS, Substantially Equivalent on 2009-10-05. Applicant: Ulrich GmbH & Co. KG.

Clearance details

Applicant: Ulrich GmbH & Co. KG
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2009-03-27
Decision date: 2009-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.