FDA 510(k)

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System

Número K: K180822 · 2019-01-28

Data da decisão2019-01-28

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Wenzel Spine, Inc.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K180822. 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 VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System?

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Wenzel Spine, Inc.. The 510(k) number is K180822.

When did VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System receive FDA 510(k) clearance?

VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System received FDA 510(k) clearance on 2019-01-28, under 510(k) number K180822.

Who is the listed applicant for VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System?

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

What is the FDA product code for VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System?

The FDA product code for VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System is MAX.

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

K262595VariLift-C Cervical Interbody Fusion System K250247panaSIa SI Fusion System K231076VariLift®-C Interbody Fusion System K231807primaLOK™ SP Interspinous Fusion System

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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