FDA 510(k)

EVOL ha - D Lateral Interbody Fusion System

Número K: K192497 · 2020-01-06

Data da decisão2020-01-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOL ha - D Lateral Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K192497. 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 EVOL ha - D Lateral Interbody Fusion System?

EVOL ha - D Lateral Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K192497.

When did EVOL ha - D Lateral Interbody Fusion System receive FDA 510(k) clearance?

EVOL ha - D Lateral Interbody Fusion System received FDA 510(k) clearance on 2020-01-06, under 510(k) number K192497.

Who is the listed applicant for EVOL ha - D Lateral Interbody Fusion System?

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

What is the FDA product code for EVOL ha - D Lateral Interbody Fusion System?

The FDA product code for EVOL ha - D Lateral Interbody Fusion System is MAX.

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Outros registros que listam Cutting Edge Spine, LLC como candidato(a)

K250605EVOL® ha – Hyper C Cervical Interbody Fusion System K230689T-FIX™ 3DSI Joint Fusion System K214123T-FIX® 3DSI Joint Fusion System K200991EVOL Spinal Interbody System K200552EVOS Lumbar Interbody System K190025EVOL® -SI Joint Fusion 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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