DURAGEN II DURAL REGENERATION MATRIX— 510(k) K043427

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K043427 for DURAGEN II DURAL REGENERATION MATRIX, Substantially Equivalent on 2005-01-12. Applicant: Integra Lifesciences Corp..

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2004-12-13
Decision date: 2005-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Plainsboro, NJ, US

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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.