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FDA 510(k)

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set

K-Number: K191148 · 2019-09-12

Decision Date2019-09-12
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-09-12 under approval number K191148. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K191148.

When was Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set approved by the FDA?

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set received FDA 510(k) clearance on 2019-09-12, under approval number K191148.

What company makes Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set?

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set is manufactured by Medtronic Sofamor Danek USA, Inc..

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

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.