DURAGEN SECURE DURAL REGNERATION MATRIX— 510(k) K120600

Name: FDA 510(k) clearance K120600
Creator: U.S. Food and Drug Administration
Published: 2012-06-15

Substantially Equivalent

Integra Life Sciences

FDA 510(k) clearance K120600 for DURAGEN SECURE DURAL REGNERATION MATRIX, Substantially Equivalent on 2012-06-15. Applicant: Integra Life Sciences. Device class: 2.

Clearance details

Applicant: Integra Life Sciences
Product code: Code GXQ
Device class: Class 2
Regulation: 21 CFR 882.5910
Advisory panel: Neurology
Date received: 2012-02-28
Decision date: 2012-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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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.