FDA 510(k)

Sistema de Fusão Interbody Lumbar Align

Número K: K221535 · 2022-07-22

Data da decisão2022-07-22

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Align Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K221535. 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 Align Lumbar Interbody Fusion System?

Align Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K221535.

When did Align Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Align Lumbar Interbody Fusion System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K221535.

Who is the listed applicant for Align Lumbar Interbody Fusion System?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Align Lumbar Interbody Fusion System?

The FDA product code for Align Lumbar Interbody Fusion System is MAX.

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Outros registros que listam Acuity Surgical Devices, LLC como candidato(a)

K251735Stabilis SA Cervical Stand-Alone System (Various PNs)K251335Tera Lumbar Interbody Fusion System (Various PNs)K243386Ventris Intervertebral Body Fusion Device K241413sagAlign Lumbar Cage System (Various PNs)K230639Align Cervical Interbody Fusion System K222561Align

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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