FDA 510(k)

Sistema de Fusão Interespinos da Coluna Spinal Altus

Número K: K160976 · 2017-01-25

Data da decisão2017-01-25

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Altus Spine Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2017-01-25 under 510(k) number K160976. 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 Altus Spine Interbody Fusion System?

Altus Spine Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-01-25. The listed applicant is Altus Partners, LLC. The 510(k) number is K160976.

When did Altus Spine Interbody Fusion System receive FDA 510(k) clearance?

Altus Spine Interbody Fusion System received FDA 510(k) clearance on 2017-01-25, under 510(k) number K160976.

Who is the listed applicant for Altus Spine Interbody Fusion System?

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

What is the FDA product code for Altus Spine Interbody Fusion System?

The FDA product code for Altus Spine Interbody Fusion System is MAX.

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Outros registros que listam Altus Partners, LLC como candidato(a)

K243419Sistema de Navegação de Coluna Vertebroespinal Altus K211027Sistema de Parafusos Pediculares de Coluna Vertebroespinal Altus K211837Sistema de Fusão Interespinos Independente da Coluna Spinal Altus K210887Sistema de OCT Espinal Sochi da Coluna Vertebroespinal Altus K200922Sistema de Parafuso Pedicular HA de Coluna Spinal Altus K200322Sistema de Parafusos Pediculares de Coluna Vertebroespinal Altus

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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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