FDA 510(k)

XYcor® Expandable Spinal Spacer System

Número K: K160646 · 2016-08-24

Data da decisão2016-08-24

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

XYcor® Expandable Spinal Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2016-08-24 under 510(k) number K160646. 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 XYcor® Expandable Spinal Spacer System?

XYcor® Expandable Spinal Spacer System is a medical device that received FDA 510(k) clearance on 2016-08-24. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K160646.

When did XYcor® Expandable Spinal Spacer System receive FDA 510(k) clearance?

XYcor® Expandable Spinal Spacer System received FDA 510(k) clearance on 2016-08-24, under 510(k) number K160646.

Who is the listed applicant for XYcor® Expandable Spinal Spacer System?

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

What is the FDA product code for XYcor® Expandable Spinal Spacer System?

The FDA product code for XYcor® Expandable Spinal Spacer System is MAX.

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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