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Eit Cellular Titanium Lumbar Cage - T/PLIF

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183447

by EIT Emerging Implant Technologies GmbH

Identifiers

510(k) Number
K183447 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 - T/PLIF is a spinal implant manufactured from a titanium alloy. It is designed for the posterior stabilization of the lumbar spinal column during Transforaminal Lumbar Interbody Fusion and Posterior Lumbar Interbody Fusion procedures.

This device is indicated for use in combination with supplemental fixation and autogenous bone graft. It has received FDA 510(k) clearance under the identifier K183447.

Frequently asked questions

What is the primary clinical use of the EIT Cellular Titanium Lumbar Cage?

This device is designed for the posterior stabilization of the lumbar spinal column. It is specifically intended for use during Transforaminal Lumbar Interbody Fusion (TLIF) and Posterior Lumbar Interbody Fusion (PLIF) procedures.

What materials are used to manufacture this lumbar cage?

The EIT Cellular Lumbar Cage is manufactured from a titanium alloy. This material is selected to provide the structural support required for spinal stabilization during fusion procedures.

Are there specific requirements for using this implant during surgery?

Yes, the device is indicated for use in combination with supplemental fixation and autogenous bone graft. These components are necessary to support the fusion process as intended by the manufacturer.

What is the regulatory status of this spinal implant?

The EIT Cellular Titanium Lumbar Cage has received FDA 510(k) clearance under the identifier K183447. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: PDF EIT Cellular Titanium® PLIF Cage, EIT Cellular Titanium Lumbar Cage - T/PLIF (K183447) — FDA 510(k ..., EIT Cellular Titanium Lumbar Cage - T/PLIF, K183447 FDA 510(k) - EIT Cellular Titanium Lumbar Cage - T/PLIF

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
EIT Emerging Implant Technologies GmbH

Sources (1)

  • FDA 510(k) K183447 24 fields · synced Sep 26, 2026