FDA 510(k)

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

N.º K: K253941 · 2026-01-07

SolicitanteMedtronic Sofamor Danek USA, Inc.

Fecha de decisión2026-01-07

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K253941. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)?

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253941.

When did CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) receive FDA 510(k) clearance?

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) received FDA 510(k) clearance on 2026-01-07, under 510(k) number K253941.

Who is the listed applicant for CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)?

The FDA product code for CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) is NKB.

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Fuente oficial

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