K152481

Substantially Equivalent

DURAFORM Dural Graft Implant

Applicant: Codman & Shurtleff, Inc.
Product code: GXQ
Advisory panel: Neurology
Date received: 2015-08-31
Decision date: 2015-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.