← Back to catalogue

Eit Cellular Titanium Lumbar Cage Llif

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181644

by EIT Emerging Implant Technologies GmbH

Identifiers

510(k) Number
K181644 FDA 510(k)
FDA Product Code
MAX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EIT Cellular Titanium Lumbar Cage LLIF is an implant manufactured from a titanium alloy designed for intervertebral body fusion procedures. It is indicated for use in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1, including patients with up to Grade 1 spondylolisthesis.

This device is authorized under FDA 510(k) clearance K181644. It is intended for use in patients where discogenic back pain and disc degeneration have been confirmed by patient history and radiographic studies.

Frequently asked questions

What is the intended use of the EIT Cellular Titanium Lumbar Cage LLIF?

The EIT Cellular Titanium Lumbar Cage LLIF is a titanium alloy implant designed for intervertebral body fusion procedures. It is specifically indicated for skeletally mature patients suffering from degenerative disc disease at one or two contiguous levels from L2 to S1, including those with Grade 1 spondylolisthesis.

What is the regulatory status of this lumbar cage?

This device is authorized for use under FDA 510(k) clearance K181644. This regulatory pathway confirms the device has been found substantially equivalent to legally marketed predicate devices for the specified clinical indications.

How is patient candidacy for this implant determined?

The device is intended for patients where discogenic back pain and disc degeneration have been confirmed through a combination of patient history and radiographic studies.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EIT Cellular Titanium® Lumbar Cage LLIF (K181644) — FDA 510 (k ..., PDF EIT Emerging Implant Technologies GmbH, K181644 FDA 510(k) - EIT Cellular Titanium Lumbar Cage LLIF, PDF Core CMI Ibuprofen/Codeine combination analgesic

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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

Manufacturer

Manufacturer
EIT Emerging Implant Technologies GmbH

Sources (1)

  • FDA 510(k) K181644 24 fields · synced Oct 6, 2026