FDA 510(k)

VersaLift Expandable System

Número K: K260837 · 2026-05-12

Data da decisão2026-05-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VersaLift 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 2026-05-12 under 510(k) number K260837. 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 VersaLift Expandable System?

VersaLift Expandable System is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Life Spine, Inc.. The 510(k) number is K260837.

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

VersaLift Expandable System received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260837.

Who is the listed applicant for VersaLift 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 VersaLift Expandable System?

The FDA product code for VersaLift Expandable System is MAX.

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

K261430TruLift Expandable System K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments 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)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Fonte oficial

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