FDA 510(k)

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement

Numéro K : K201362 · 2020-08-19

Date de décision2020-08-19

Code produitPML

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K201362. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement?

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Medtronic. The 510(k) number is K201362.

When did CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement receive FDA 510(k) clearance?

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement received FDA 510(k) clearance on 2020-08-19, under 510(k) number K201362.

Who is the listed applicant for CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement?

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

What is the FDA product code for CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement?

The FDA product code for CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement is PML.

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Dispositifs connexes (Code : PML)

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Source officielle

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