FDA 510(k)

Atlas Spine Rebar (Ti) Spacer System

Número K: K202302 · 2020-10-30

Data da decisão2020-10-30

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Atlas Spine Rebar (Ti) Spacer 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 2020-10-30 under 510(k) number K202302. 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 Atlas Spine Rebar (Ti) Spacer System?

Atlas Spine Rebar (Ti) Spacer System is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K202302.

When did Atlas Spine Rebar (Ti) Spacer System receive FDA 510(k) clearance?

Atlas Spine Rebar (Ti) Spacer System received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202302.

Who is the listed applicant for Atlas Spine Rebar (Ti) Spacer 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 Rebar (Ti) Spacer System?

The FDA product code for Atlas Spine Rebar (Ti) Spacer System is ODP.

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

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Dispositivos Relacionados (Código: ODP)

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Fonte oficial

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