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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 the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2022-04-18 under 510(k) 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. The listed applicant is Tecres S.P.A.. The 510(k) number is K220131.

When did KYPHON VuE Bone Cement receive FDA 510(k) clearance?

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

Who is the listed applicant for KYPHON VuE Bone Cement?

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

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

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

Other records listing Tecres S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252326InterSpace GV Hip SpacerK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVK181732InterSpace Knee Extra-Large Size, InterSpace Knee ATS

Related Devices (Code: NDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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.

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