← Back to catalogue

Ti-Diagon Oblique TLIF

FDA UDI

Class II (US FDA UDI)

by Camber Spine Technologies

Identity

Trade Name
Ti-Diagon Oblique TLIF FDA UDI
Generic Name
Metallic spinal fusion cage, non-sterile FDA UDI
Device Name
TLIF Implant, 28mm x 11mm, 17mm, 15° Lordotic FDA UDI
Model / Reference
DIT-2811-1517 FDA UDI
Description
TLIF Implant, 28mm x 11mm, 17mm, 15° Lordotic FDA UDI

Identifiers

Primary DI / UDI-DI
B030DIT281115170 FDA UDI
510(k) Number
K172064 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Metallic spinal fusion cage, non-sterile 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

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Metallic spinal fusion cage, non-sterile

Ti-Diagon Oblique TLIF by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal fusion cage, non-sterile.

Cleared under the same submission

K172064 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Camber Spine Technologies

Sources (1)

  • FDA UDI a5f22e62-a858-4683-a1a9-46603e7da1c0 35 fields · synced May 31, 2026