FDA 510(k)

ulrichINJECT CT Motion (XD 8000)

Número K: K251295 · 2025-11-07

Data da decisão2025-11-07

Código do produtoIZQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ulrichINJECT CT Motion (XD 8000) is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K251295. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ulrichINJECT CT Motion (XD 8000)?

ulrichINJECT CT Motion (XD 8000) is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K251295.

When did ulrichINJECT CT Motion (XD 8000) receive FDA 510(k) clearance?

ulrichINJECT CT Motion (XD 8000) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K251295.

Who is the listed applicant for ulrichINJECT CT Motion (XD 8000)?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ulrichINJECT CT Motion (XD 8000)?

The FDA product code for ulrichINJECT CT Motion (XD 8000) is IZQ.

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Outros registros que listam Ulrich GmbH & Co. KG como candidato(a)

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motion K202227Artus™ cervical plate system K192872ulrichINJECT CT Motion

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: IZQ)

Fonte oficial

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