FDA 510(k)

Atlas Spine Expandable Cervical Interbody System

N.º K: K180675 · 2018-06-13

Fecha de decisión2018-06-13

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Atlas Spine Expandable Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180675. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Atlas Spine Expandable Cervical Interbody System?

Atlas Spine Expandable Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K180675.

When did Atlas Spine Expandable Cervical Interbody System receive FDA 510(k) clearance?

Atlas Spine Expandable Cervical Interbody System received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180675.

Who is the listed applicant for Atlas Spine Expandable Cervical Interbody System?

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

What is the FDA product code for Atlas Spine Expandable Cervical Interbody System?

The FDA product code for Atlas Spine Expandable Cervical Interbody System is ODP.

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Otros registros que enlistan a Atlas Spine, Inc. como solicitante

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy System K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody System K243191Atlas Spine Lateral Expandable Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System

Ver todos los 10 dispositivos →

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.

Fuente oficial

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