FDA 510(k)

neon3™ universal OCT spinal stabilization

Número K: K161032 · 2016-12-22

Data da decisão2016-12-22

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

neon3™ universal OCT spinal stabilization is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K161032. 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 neon3™ universal OCT spinal stabilization?

neon3™ universal OCT spinal stabilization is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K161032.

When did neon3™ universal OCT spinal stabilization receive FDA 510(k) clearance?

neon3™ universal OCT spinal stabilization received FDA 510(k) clearance on 2016-12-22, under 510(k) number K161032.

Who is the listed applicant for neon3™ universal OCT spinal stabilization?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neon3™ universal OCT spinal stabilization?

The FDA product code for neon3™ universal OCT spinal stabilization is NKG.

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Outros registros que listam Ulrich GmbH & Co. KG como candidato(a)

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K251295ulrichINJECT CT Motion (XD 8000)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motion K202227Artus™ cervical plate 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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