MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX— 510(k) K063117

Name: FDA 510(k) clearance K063117
Creator: U.S. Food and Drug Administration
Published: 2006-11-03

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K063117 for MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX, Substantially Equivalent on 2006-11-03. Applicant: Medtronic Neurosurgery. Device class: 2.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code GXQ
Device class: Class 2
Regulation: 21 CFR 882.5910
Advisory panel: Neurology
Date received: 2006-10-12
Decision date: 2006-11-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Goleta, CA, 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.