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NeoFuse Ti3D PLIF/TLIF

FDA UDI

Class II (US FDA UDI)

by Xenix Medical

Identity

Trade Name
NeoFuse Ti3D PLIF/TLIF FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
Ti3D CAGE 30L x 12W x 11H FDA UDI
Model / Reference
C3012-11 FDA UDI
Description
Ti3D CAGE 30L x 12W x 11H FDA UDI

Identifiers

Primary DI / UDI-DI
00818345021754 FDA UDI
510(k) Number
K170318 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

NeoFuse Ti3D PLIF/TLIF by Xenix Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K170318 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 8c419485-7374-4d0f-a90c-c1414d2c5ee7 36 fields · synced Jun 1, 2026