FDA 510(k)

EVOL Spinal Interbody System, EVOS Lumbar Interbody System

Numéro K : K180891 · 2018-05-04

Date de décision2018-05-04

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

EVOL Spinal Interbody System, EVOS Lumbar Interbody 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 2018-05-04 under 510(k) number K180891. 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 EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K180891.

When did EVOL Spinal Interbody System, EVOS Lumbar Interbody System receive FDA 510(k) clearance?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System received FDA 510(k) clearance on 2018-05-04, under 510(k) number K180891.

Who is the listed applicant for EVOL Spinal Interbody System, EVOS Lumbar Interbody 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 Spinal Interbody System, EVOS Lumbar Interbody System?

The FDA product code for EVOL Spinal Interbody System, EVOS Lumbar Interbody System is MAX.

Essais cliniques associés

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Autres dossiers indiquant Cutting Edge Spine, LLC en tant que demandeur

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Dispositifs connexes (Code : MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Système Interbody ExpansibleMedtronic 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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