FDA 510(k)

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

Numéro K : K180822 · 2019-01-28

Date de décision2019-01-28

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Wenzel Spine, Inc. en tant que demandeur

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Dispositifs connexes (Code : 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 SySeaSpine Orthopedics Corporation K253151Système de Cage de Fusion Intervertébral FuleBeijing Fule Science & Technology Development Co., Ltd.

Source officielle

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