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FDA 510(k)

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

N.º K: K152604 · 2016-01-06

SolicitanteMedtronic Sofamor Danek USA, Incorporated
Fecha de decisión2016-01-06
Código de productoPML
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Incorporated. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K152604. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Medtronic Sofamor Danek USA, Incorporated. The 510(k) number is K152604.

When did KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set receive FDA 510(k) clearance?

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2016-01-06, under 510(k) number K152604.

Who is the listed applicant for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set?

The FDA product code for KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set is PML.

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Dispositivos relacionados (Código: PML)

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.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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