Longeviti PMMA Static Cranial Implant— 510(k) K210616

Substantially Equivalent

Longeviti Neuro Solutions, LLC

FDA 510(k) clearance K210616 for Longeviti PMMA Static Cranial Implant, Substantially Equivalent on 2021-03-31. Applicant: Longeviti Neuro Solutions, LLC.

Clearance details

Applicant: Longeviti Neuro Solutions, LLC
Product code: Code GXN
Advisory panel: Neurology
Date received: 2021-03-01
Decision date: 2021-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Hunt Valley, MD, US

Download summary PDF View on FDA.gov ↗

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.