FDA 510(k)

Spine Guidance Software, Stryker Q Guidance System

N.º K: K220593 · 2022-05-27

SolicitanteStryker Leibinger GmbH & Co KG

Fecha de decisión2022-05-27

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Spine Guidance Software, Stryker Q Guidance 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 2022-05-27 under 510(k) number K220593. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Spine Guidance Software, Stryker Q Guidance System?

Spine Guidance Software, Stryker Q Guidance System is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K220593.

When did Spine Guidance Software, Stryker Q Guidance System receive FDA 510(k) clearance?

Spine Guidance Software, Stryker Q Guidance System received FDA 510(k) clearance on 2022-05-27, under 510(k) number K220593.

Who is the listed applicant for Spine Guidance Software, Stryker Q Guidance 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 Spine Guidance Software, Stryker Q Guidance System?

The FDA product code for Spine Guidance Software, Stryker Q Guidance System is OLO.

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Otros registros que enlistan a Stryker Leibinger GmbH & Co KG como solicitante

K261054RibPlate System K254233MEDPOR Customized Implant Kit K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories K243491SternalPlate Expansion K241517Q Guidance System; Mako Spine System;

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Fuente oficial

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