FDA 510(k)

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

Número K: K152604 · 2016-01-06

RequerenteMedtronic Sofamor Danek USA, Incorporated

Data da decisão2016-01-06

Código do produtoPML

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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