FDA 510(k)

Sistema de Fusão Interbody Ali

Número K: K203308 · 2021-01-15

Data da decisão2021-01-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ali Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Raed M. Ali, M.D., Inc.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203308. 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 Ali Interbody Fusion System?

Ali Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Raed M. Ali, M.D., Inc.. The 510(k) number is K203308.

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

Ali Interbody Fusion System received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203308.

Who is the listed applicant for Ali Interbody Fusion System?

The FDA 510(k) record lists Raed M. Ali, M.D., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ali Interbody Fusion System?

The FDA product code for Ali Interbody Fusion System is MAX.

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Outros registros que listam Raed M. Ali, M.D., Inc. como candidato(a)

K191516Sistema de Fusão Interbody Ali

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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