FDA 510(k)

X-PAC® LLIF Expandable Lateral Cage System

Número K: K251003 · 2025-06-25

Data da decisão2025-06-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

X-PAC® LLIF Expandable Lateral Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K251003. 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 X-PAC® LLIF Expandable Lateral Cage System?

X-PAC® LLIF Expandable Lateral Cage System is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Expanding Innovations, Inc.. The 510(k) number is K251003.

When did X-PAC® LLIF Expandable Lateral Cage System receive FDA 510(k) clearance?

X-PAC® LLIF Expandable Lateral Cage System received FDA 510(k) clearance on 2025-06-25, under 510(k) number K251003.

Who is the listed applicant for X-PAC® LLIF Expandable Lateral Cage System?

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

What is the FDA product code for X-PAC® LLIF Expandable Lateral Cage System?

The FDA product code for X-PAC® LLIF Expandable Lateral Cage System is MAX.

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Outros registros que listam Expanding Innovations, Inc. como candidato(a)

K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System K250602X-PAC® N-GAGE™ Lumbar Plate System K223174X-Pac Expandable LLIF Cage System K222797X-Pac Expandable Lumbar Cage System K220655X-Pac Expandable Lumbar Cage System K203802X-Pac Expandable Lumbar Cage System

Ver todos os 8 dispositivos →

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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