FDA 510(k)

Q Guidance System; Mako Spine System;

Número K: K241517 · 2024-08-27

RequerenteStryker Leibinger GmbH & Co KG

Data da decisão2024-08-27

Código do produtoOLO

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Q Guidance System; Mako Spine System; is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K241517. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Q Guidance System; Mako Spine System;?

Q Guidance System; Mako Spine System; is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K241517.

When did Q Guidance System; Mako Spine System; receive FDA 510(k) clearance?

Q Guidance System; Mako Spine System; received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241517.

Who is the listed applicant for Q Guidance System; Mako Spine System;?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Guidance System; Mako Spine System;?

The FDA product code for Q Guidance System; Mako Spine System; is OLO.

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Fonte oficial

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