Kyphon VuE™ Bone Cement

FDA UDI

Class II (US FDA UDI)

by Tecres

Identity

Trade Name: Kyphon VuE™ Bone Cement FDA UDI
Generic Name: Orthopaedic cement, non-antimicrobial FDA UDI
Model / Reference: CT01A FDA UDI

Identifiers

Primary DI / UDI-DI: 08031497002538 FDA UDI
510(k) Number: K220131 FDA UDI
FDA Product Code: NDN FDA UDI
GMDN Term: Orthopaedic cement, non-antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic cement, non-antimicrobial

Kyphon VuE™ Bone Cement by Tecres — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K220131 also covers:

Kyphon VuE Bone Cement and Kyphon Mixer — MEDTRONIC SOFAMOR DANEK, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tecres

Sources (1)

FDA UDI da944ff8-4552-4147-aab8-5f532b0a17b9 33 fields · synced May 30, 2026