FDA 510(k)

Certex Spinal Fixation System

Número K: K160428 · 2016-05-05

Data da decisão2016-05-05

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Certex Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K160428. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Certex Spinal Fixation System?

Certex Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K160428.

When did Certex Spinal Fixation System receive FDA 510(k) clearance?

Certex Spinal Fixation System received FDA 510(k) clearance on 2016-05-05, under 510(k) number K160428.

Who is the listed applicant for Certex Spinal Fixation System?

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

What is the FDA product code for Certex Spinal Fixation System?

The FDA product code for Certex Spinal Fixation System is NKG.

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Outros registros que listam X-Spine Systems, Inc. como candidato(a)

K173832InTice™-C Porous Ti Cervical Interbody System K180153X-spine Cortical Bone Screw System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K171075Calix-C Cervical Interbody Spacer K170224Spider Cervical Plating System

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Dispositivos Relacionados (Código: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.

Fonte oficial

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