FDA 510(k)

Paramount Anterior Cervical Cage System

Número K: K173175 · 2017-11-01

Data da decisão2017-11-01

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Paramount Anterior Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K173175. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Paramount Anterior Cervical Cage System?

Paramount Anterior Cervical Cage System is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is Spine Wave, Inc.. The 510(k) number is K173175.

When did Paramount Anterior Cervical Cage System receive FDA 510(k) clearance?

Paramount Anterior Cervical Cage System received FDA 510(k) clearance on 2017-11-01, under 510(k) number K173175.

Who is the listed applicant for Paramount Anterior Cervical Cage System?

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

What is the FDA product code for Paramount Anterior Cervical Cage System?

The FDA product code for Paramount Anterior Cervical Cage System is OVE.

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Outros registros que listam Spine Wave, Inc. como candidato(a)

K260286Dynamo™ Spinal Cement; Salvo® Spine System K261159Exceed® Biplanar Expandable Interbody System K243816Testa TP Pivoting Spacer System K251131Annex® 2 Adjacent Level System K243514Salvo® Robotic Navigation Instruments K240685Salvo® Spine System

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Dispositivos Relacionados (Código: OVE)

K263049SABER-C SystemElevation Spine K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

Fonte oficial

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