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FDA 510(k)

K5 Cart, K5 Mount, K5 Swing

N.º K: K251491 · 2025-07-17

SolicitanteOsstem Implant Company., Ltd. Chair Business
Fecha de decisión2025-07-17
Código de productoEIA
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

K5 Cart, K5 Mount, K5 Swing is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Company., Ltd. Chair Business. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K251491. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the K5 Cart, K5 Mount, K5 Swing?

K5 Cart, K5 Mount, K5 Swing is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Osstem Implant Company., Ltd. Chair Business. The 510(k) number is K251491.

When did K5 Cart, K5 Mount, K5 Swing receive FDA 510(k) clearance?

K5 Cart, K5 Mount, K5 Swing received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251491.

Who is the listed applicant for K5 Cart, K5 Mount, K5 Swing?

The FDA 510(k) record lists Osstem Implant Company., Ltd. Chair Business as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K5 Cart, K5 Mount, K5 Swing?

The FDA product code for K5 Cart, K5 Mount, K5 Swing is EIA.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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