FDA 510(k)

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices

Número K: K190193 · 2019-03-04

Data da decisão2019-03-04

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is the device name listed in this FDA 510(k) record. The listed applicant is Spineex, Inc.. It received FDA 510(k) clearance on 2019-03-04 under 510(k) number K190193. 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 SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices?

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2019-03-04. The listed applicant is Spineex, Inc.. The 510(k) number is K190193.

When did SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices receive FDA 510(k) clearance?

SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices received FDA 510(k) clearance on 2019-03-04, under 510(k) number K190193.

Who is the listed applicant for SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices?

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

What is the FDA product code for SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices?

The FDA product code for SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices is MAX.

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

K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

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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