Ti3D CERVICAL

FDA UDI

Class II (US FDA UDI)

by Xenix Medical

Identity

Trade Name: Ti3D CERVICAL FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: Ti3D C Cervical Trials, 14W x 12D x 9H, 6 DEG FDA UDI
Model / Reference: B242-09 FDA UDI
Description: Ti3D C Cervical Trials, 14W x 12D x 9H, 6 DEG FDA UDI

Identifiers

Catalog Number: N/A FDA UDI
Primary DI / UDI-DI: 00818345023635 FDA UDI
510(k) Number: K170318 FDA UDI
K222988 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Ti3D CERVICAL by Xenix Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MLX — Nuvasive, Inc. · Class I
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ROI-A — Ldr Spine USA · Class II

Cleared under the same submission

K170318 also covers:

K222988 also covers:

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: Xenix Medical

Sources (1)

FDA UDI 59862159-355b-487c-8e8d-daeb503ff4b0 36 fields · synced May 30, 2026