FDA 510(k)

SPIRA-C Open Matrix Cervical Interbody

Número K: K172446 · 2017-11-07

Data da decisão2017-11-07

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPIRA-C Open Matrix Cervical Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2017-11-07 under 510(k) number K172446. 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 SPIRA-C Open Matrix Cervical Interbody?

SPIRA-C Open Matrix Cervical Interbody is a medical device that received FDA 510(k) clearance on 2017-11-07. The listed applicant is Camber Spine Technologies. The 510(k) number is K172446.

When did SPIRA-C Open Matrix Cervical Interbody receive FDA 510(k) clearance?

SPIRA-C Open Matrix Cervical Interbody received FDA 510(k) clearance on 2017-11-07, under 510(k) number K172446.

Who is the listed applicant for SPIRA-C Open Matrix Cervical Interbody?

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

What is the FDA product code for SPIRA-C Open Matrix Cervical Interbody?

The FDA product code for SPIRA-C Open Matrix Cervical Interbody is ODP.

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Outros registros que listam Camber Spine Technologies como candidato(a)

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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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