FDA 510(k)

EIT Cellular Titanium® Lumbar Cage LLIF

K-Number: K181644 · 2018-10-12

ApplicantEit Emerging Implant Technologies GmbH

Decision Date2018-10-12

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EIT Cellular Titanium® Lumbar Cage LLIF is the device name listed in this FDA 510(k) record. The listed applicant is Eit Emerging Implant Technologies GmbH. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181644. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EIT Cellular Titanium® Lumbar Cage LLIF?

EIT Cellular Titanium® Lumbar Cage LLIF is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Eit Emerging Implant Technologies GmbH. The 510(k) number is K181644.

When did EIT Cellular Titanium® Lumbar Cage LLIF receive FDA 510(k) clearance?

EIT Cellular Titanium® Lumbar Cage LLIF received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181644.

Who is the listed applicant for EIT Cellular Titanium® Lumbar Cage LLIF?

The FDA 510(k) record lists Eit Emerging Implant Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EIT Cellular Titanium® Lumbar Cage LLIF?

The FDA product code for EIT Cellular Titanium® Lumbar Cage LLIF is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07777718Lumbar Fusion With Nanotube Versus Titanium CageNOT_YET_RECRUITING

Other records listing Eit Emerging Implant Technologies GmbH as applicant

Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.