FDA 510(k)

Spectrum Spine Expandable Cages (SSEC)

Número K: K173518 · 2019-03-07

Data da decisão2019-03-07

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spectrum Spine Expandable Cages (SSEC) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine, LLC. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K173518. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spectrum Spine Expandable Cages (SSEC)?

Spectrum Spine Expandable Cages (SSEC) is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Spectrum Spine, LLC. The 510(k) number is K173518.

When did Spectrum Spine Expandable Cages (SSEC) receive FDA 510(k) clearance?

Spectrum Spine Expandable Cages (SSEC) received FDA 510(k) clearance on 2019-03-07, under 510(k) number K173518.

Who is the listed applicant for Spectrum Spine Expandable Cages (SSEC)?

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

What is the FDA product code for Spectrum Spine Expandable Cages (SSEC)?

The FDA product code for Spectrum Spine Expandable Cages (SSEC) is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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