FDA 510(k)

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

K-Number: K171938 · 2017-10-23

Decision Date2017-10-23

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2017-10-23 under approval number K171938. 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 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set?

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Medtronic. The 510(k) number is K171938.

When was KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set approved by the FDA?

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set received FDA 510(k) clearance on 2017-10-23, under approval number K171938.

What company makes KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set?

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is manufactured by Medtronic.

What is the FDA product code for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set?

The FDA product code for KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set is PML.

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Related Devices (Code: 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.