FDA 510(k)

Sistema de Placa Craniana de Titânio 3D MAC (TCP)

Número K: K253116 · 2026-06-18

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

Data da decisão2026-06-18

Código do produtoGXN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

3D MAC Titanium Cranial Plate (TCP) System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253116. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3D MAC Titanium Cranial Plate (TCP) System?

3D MAC Titanium Cranial Plate (TCP) System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is The Surgeon General, Department of the Army (TSG-DA). The 510(k) number is K253116.

When did 3D MAC Titanium Cranial Plate (TCP) System receive FDA 510(k) clearance?

3D MAC Titanium Cranial Plate (TCP) System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253116.

Who is the listed applicant for 3D MAC Titanium Cranial Plate (TCP) System?

The FDA 510(k) record lists The Surgeon General, Department of the Army (TSG-DA) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D MAC Titanium Cranial Plate (TCP) System?

The FDA product code for 3D MAC Titanium Cranial Plate (TCP) System is GXN.

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