FDA 510(k)

Leva Anterior Expandable Spacer System

Número K: K163246 · 2017-04-06

Data da decisão2017-04-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Leva Anterior Expandable Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K163246. 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 Leva Anterior Expandable Spacer System?

Leva Anterior Expandable Spacer System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Spine Wave, Inc.. The 510(k) number is K163246.

When did Leva Anterior Expandable Spacer System receive FDA 510(k) clearance?

Leva Anterior Expandable Spacer System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K163246.

Who is the listed applicant for Leva Anterior Expandable Spacer System?

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

What is the FDA product code for Leva Anterior Expandable Spacer System?

The FDA product code for Leva Anterior Expandable Spacer System is MAX.

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

K260286Dynamo™ Spinal Cement; Salvo® Spine System K261159Exceed® Biplanar Expandable Interbody System K243816Testa TP Pivoting Spacer System K251131Annex® 2 Adjacent Level System K243514Salvo® Robotic Navigation Instruments K240685Salvo® Spine 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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