FDA 510(k)

Calix-C Cervical Interbody Spacer

Número K: K171075 · 2017-08-01

Data da decisão2017-08-01

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Calix-C Cervical Interbody Spacer is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K171075. 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 Calix-C Cervical Interbody Spacer?

Calix-C Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K171075.

When did Calix-C Cervical Interbody Spacer receive FDA 510(k) clearance?

Calix-C Cervical Interbody Spacer received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171075.

Who is the listed applicant for Calix-C Cervical Interbody Spacer?

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

What is the FDA product code for Calix-C Cervical Interbody Spacer?

The FDA product code for Calix-C Cervical Interbody Spacer is ODP.

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Outros registros que listam X-Spine Systems, Inc. como candidato(a)

K173832InTice™-C Porous Ti Cervical Interbody System K180153X-spine Cortical Bone Screw System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K170224Spider Cervical Plating System K170530Butrex Lumbar Buttress Plating System

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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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