3D MAC Titanium Cranial Plate (TCP) System— 510(k) K253116

Name: FDA 510(k) clearance K253116
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

The Surgeon General, Department of the Army (TSG-DA)

FDA 510(k) clearance K253116 for 3D MAC Titanium Cranial Plate (TCP) System, Substantially Equivalent on 2026-06-18. Applicant: The Surgeon General, Department of the Army (TSG-DA). Device class: 2.

Clearance details

Applicant: The Surgeon General, Department of the Army (TSG-DA)
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2025-09-24
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Detrick, MD, US

Download summary PDF View on FDA.gov ↗

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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.