FDA 510(k)

Xsert Lumbar Expandable Interbody System

Número K: K160959 · 2016-11-17

Data da decisão2016-11-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Xsert Lumbar Expandable Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K160959. 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 Xsert Lumbar Expandable Interbody System?

Xsert Lumbar Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K160959.

When did Xsert Lumbar Expandable Interbody System receive FDA 510(k) clearance?

Xsert Lumbar Expandable Interbody System received FDA 510(k) clearance on 2016-11-17, under 510(k) number K160959.

Who is the listed applicant for Xsert Lumbar Expandable Interbody System?

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

What is the FDA product code for Xsert Lumbar Expandable Interbody System?

The FDA product code for Xsert Lumbar Expandable Interbody System is MAX.

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Outros registros que listam X-Spine Systems, Inc. como candidato(a)

K173832InTice™-C Porous Ti Cervical Interbody System K180153X-spine Cortical Bone Screw System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K171075Calix-C Cervical Interbody Spacer K170224Spider Cervical Plating 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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