K072929

Substantially Equivalent

LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030

Applicant: Integra LifeSciences Corporation
Product code: JXG
Advisory panel: Neurology
Date received: 2007-10-16
Decision date: 2007-12-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, US

Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.