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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
Cervical Trial, 12W x 11.5D x 12H, 6 DEG FDA UDI
Model / Reference
B221-12 FDA UDI
Description
Cervical Trial, 12W x 11.5D x 12H, 6 DEG FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00818345023581 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K170318 also covers:

K222988 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xenix Medical

Sources (1)

  • FDA UDI adb319e3-6c94-48f3-a3bb-70a2c5854faa 36 fields · synced Jun 6, 2026