FDA 510(k)

Atlas Spine Lateral Expandable Interbody System

Número K: K243191 · 2024-11-26

Data da decisão2024-11-26

Código do produtoOVD

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Atlas Spine Lateral Expandable 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 2024-11-26 under 510(k) number K243191. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Atlas Spine Lateral Expandable Interbody System?

Atlas Spine Lateral Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K243191.

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

Atlas Spine Lateral Expandable Interbody System received FDA 510(k) clearance on 2024-11-26, under 510(k) number K243191.

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

The FDA product code for Atlas Spine Lateral Expandable Interbody System is OVD.

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

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy System K251969Atlas Spine Project X Expandable Posterior Lumbar Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System K182418V3 Segmental Plating System

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Dispositivos Relacionados (Código: OVD)

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Fonte oficial

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