FDA 510(k)

TruLift Expandable System

Número K: K261430 · 2026-07-28

Data da decisão2026-07-28

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TruLift Expandable System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2026-07-28 under 510(k) number K261430. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TruLift Expandable System?

TruLift Expandable System is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Life Spine, Inc.. The 510(k) number is K261430.

When did TruLift Expandable System receive FDA 510(k) clearance?

TruLift Expandable System received FDA 510(k) clearance on 2026-07-28, under 510(k) number K261430.

Who is the listed applicant for TruLift Expandable System?

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

What is the FDA product code for TruLift Expandable System?

The FDA product code for TruLift Expandable System is MAX.

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Outros registros que listam Life Spine, Inc. como candidato(a)

K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments K260837VersaLift Expandable System K254274Sistema de Implante SAI ARx®K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System K250373ProLift Expandable Spacer System

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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