FDA 510(k)

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System

Número K: K161404 · 2016-07-21

Data da decisão2016-07-21

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K161404. 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 Genesys Spine Apache® Lateral Lumbar Interbody Fusion System?

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Genesys Spine. The 510(k) number is K161404.

When did Genesys Spine Apache® Lateral Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System received FDA 510(k) clearance on 2016-07-21, under 510(k) number K161404.

Who is the listed applicant for Genesys Spine Apache® Lateral Lumbar Interbody Fusion System?

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

What is the FDA product code for Genesys Spine Apache® Lateral Lumbar Interbody Fusion System?

The FDA product code for Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is MAX.

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Outros registros que listam Genesys Spine como candidato(a)

K252322SIros-X System K242483Genesys Spine AIS-C II Cervical Interbody Fusion System K233595Genesys Spine Sacroiliac Joint Fusion System with Navigation K233594Genesys Spine 3DP AIS-C II Cervical Interbody System K220096Genesys Spine 3DP Lumbar Interbody System K191489Genesys Spine 3DP Cervical Interbody System

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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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