FDA 510(k)

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

N.º K: K232154 · 2023-09-11

Fecha de decisión2023-09-11

Código de productoOVD

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-09-11 under 510(k) number K232154. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a medical device that received FDA 510(k) clearance on 2023-09-11. The listed applicant is MiRus, LLC. The 510(k) number is K232154.

When did MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation receive FDA 510(k) clearance?

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation received FDA 510(k) clearance on 2023-09-11, under 510(k) number K232154.

Who is the listed applicant for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

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

What is the FDA product code for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation?

The FDA product code for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is OVD.

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Otros registros que enlistan a MiRus, LLC como solicitante

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Dispositivos relacionados (Código: OVD)

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA Innovasis K261408SABER-XA SystemElevation Spine K261809Interwedge® Standalone LateralFoundation Surgical Group K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Placa de Cubierta Anteralign LSTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Fuente oficial

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