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FDA 510(k)

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

N.º K: K212194 · 2023-02-16

Fecha de decisión2023-02-16
Código de productoHAW
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K212194. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System?

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Stryker Corporation. The 510(k) number is K212194.

When did Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System receive FDA 510(k) clearance?

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System received FDA 510(k) clearance on 2023-02-16, under 510(k) number K212194.

Who is the listed applicant for Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System?

The FDA product code for Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System is HAW.

Ensayos clínicos relacionados

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Otros registros que enlistan a Stryker Corporation como solicitante

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Ver todos los 42 dispositivos →

Dispositivos relacionados (Código: HAW)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

Fuente oficial

Ver en la base de datos de la FDA →

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