3D MAC Titanium Cranial Plate (TCP) System— 510(k) K253116
Substantially EquivalentThe 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.
Summary
The 3D MAC Titanium Cranial Plate (TCP) System is filed under GXN, preformed non-alterable cranioplasty plates. The applicant is listed as The Surgeon General, Department of the Army (TSG-DA), and the record doesn't expand the "3D MAC" part of the name.
Class II, 21 CFR 882.5330. Neurology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
The applicant filed from Fort Detrick, Maryland. Review took 267 calendar days (September 24, 2025 to June 18, 2026).
Clearance details
- Applicant
- The Surgeon General, Department of the Army (TSG-DA)
- Product code
- Product code GXN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Detrick, MD, US
Recent devices under product code GXN
view allMore clearances from The Surgeon General, Department of the Army (TSG-DA)
view allAdverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
Source: openFDA MAUDE database, through . 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.