ULTRAFUSE— 510(k) K130531

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K130531 for ULTRAFUSE, Substantially Equivalent on 2014-04-08. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2013-03-01
Decision date: 2014-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake Village, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

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.