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FDA 510(k)

KYPHON VuE Bone Cement

K-Number: K220131 · 2022-04-18

ApplicantTecres S.P.A.
Decision Date2022-04-18
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHON VuE Bone Cement is a medical device manufactured by Tecres S.P.A.. It received FDA 510(k) clearance on 2022-04-18 under approval number K220131. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KYPHON VuE Bone Cement?

KYPHON VuE Bone Cement is a medical device that received FDA 510(k) clearance on 2022-04-18. It is manufactured by Tecres S.P.A.. The 510(k) number is K220131.

When was KYPHON VuE Bone Cement approved by the FDA?

KYPHON VuE Bone Cement received FDA 510(k) clearance on 2022-04-18, under approval number K220131.

What company makes KYPHON VuE Bone Cement?

KYPHON VuE Bone Cement is manufactured by Tecres S.P.A..

What is the FDA product code for KYPHON VuE Bone Cement?

The FDA product code for KYPHON VuE Bone Cement is NDN.

Other Devices by Tecres S.P.A.

Related Devices (Code: NDN)

Official Source

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