FDA 510(k)

Ennovate Cervical Spinal and Occiput System

Número K: K213871 · 2022-07-01

Data da decisão2022-07-01

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ennovate Cervical Spinal and Occiput System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213871. 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 Ennovate Cervical Spinal and Occiput System?

Ennovate Cervical Spinal and Occiput System is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K213871.

When did Ennovate Cervical Spinal and Occiput System receive FDA 510(k) clearance?

Ennovate Cervical Spinal and Occiput System received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213871.

Who is the listed applicant for Ennovate Cervical Spinal and Occiput System?

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

What is the FDA product code for Ennovate Cervical Spinal and Occiput System?

The FDA product code for Ennovate Cervical Spinal and Occiput System is NKG.

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Outros registros que listam Aesculap Implant Systems, LLC como candidato(a)

K210963ENNOVATE Spinal System K180433ENNOVATE®K162134ENNOVATE Spinal System K153700Sistemas de Navegação de Implantes Aesculap(R) (AIS) S4 K153396Aesculap OrthoPilot Geração Próxima

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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