FDA 510(k)

ORIO-Ti Intervertebral Body Fusion Cage System

Número K: K211935 · 2021-09-30

Data da decisão2021-09-30

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ORIO-Ti Intervertebral Body Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K211935. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ORIO-Ti Intervertebral Body Fusion Cage System?

ORIO-Ti Intervertebral Body Fusion Cage System is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Spinecraft, LLC. The 510(k) number is K211935.

When did ORIO-Ti Intervertebral Body Fusion Cage System receive FDA 510(k) clearance?

ORIO-Ti Intervertebral Body Fusion Cage System received FDA 510(k) clearance on 2021-09-30, under 510(k) number K211935.

Who is the listed applicant for ORIO-Ti Intervertebral Body Fusion Cage System?

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

What is the FDA product code for ORIO-Ti Intervertebral Body Fusion Cage System?

The FDA product code for ORIO-Ti Intervertebral Body Fusion Cage System is ODP.

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Outros registros que listam Spinecraft, LLC como candidato(a)

K223301Sistema de Instrumentos de Navegação ASTRA e Sistema de Instrumentos de Navegação ASTRA-OCT K223273Sistema de Coluna ASTRA K211323Sistema de Coluna ASTRA K181350Sistema de Coluna ASTRA-OCT

Dispositivos Relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fonte oficial

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