MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520— 510(k) K013000

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K013000 for MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520, Substantially Equivalent on 2001-12-05. Applicant: Medtronic Neurosurgery.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code GXN
Advisory panel: Neurology
Date received: 2001-09-06
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.