FDA 510(k)

Foundation Surgical Navigated Lateral Disc Prep Instruments

N.º K: K260011 · 2026-04-16

SolicitanteFoundation Surgical Group, Inc.

Fecha de decisión2026-04-16

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Foundation Surgical Navigated Lateral Disc Prep Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Surgical Group, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K260011. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Foundation Surgical Navigated Lateral Disc Prep Instruments?

Foundation Surgical Navigated Lateral Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Foundation Surgical Group, Inc.. The 510(k) number is K260011.

When did Foundation Surgical Navigated Lateral Disc Prep Instruments receive FDA 510(k) clearance?

Foundation Surgical Navigated Lateral Disc Prep Instruments received FDA 510(k) clearance on 2026-04-16, under 510(k) number K260011.

Who is the listed applicant for Foundation Surgical Navigated Lateral Disc Prep Instruments?

The FDA 510(k) record lists Foundation Surgical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Foundation Surgical Navigated Lateral Disc Prep Instruments?

The FDA product code for Foundation Surgical Navigated Lateral Disc Prep Instruments is OLO.

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Dispositivos relacionados (Código: OLO)

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Fuente oficial

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