FDA 510(k)

Republic Spine Restore Intervertebral Body Fusion System

Número K: K190398 · 2019-09-12

Data da decisão2019-09-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Republic Spine Restore Intervertebral Body Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Republic Spine, LLC. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K190398. 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 Republic Spine Restore Intervertebral Body Fusion System?

Republic Spine Restore Intervertebral Body Fusion System is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Republic Spine, LLC. The 510(k) number is K190398.

When did Republic Spine Restore Intervertebral Body Fusion System receive FDA 510(k) clearance?

Republic Spine Restore Intervertebral Body Fusion System received FDA 510(k) clearance on 2019-09-12, under 510(k) number K190398.

Who is the listed applicant for Republic Spine Restore Intervertebral Body Fusion System?

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

What is the FDA product code for Republic Spine Restore Intervertebral Body Fusion System?

The FDA product code for Republic Spine Restore Intervertebral Body Fusion System is MAX.

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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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