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FDA 510(k)

EIT Cellular Titanium Lumbar Cage - T/PLIF

K-Number: K183447 · 2019-02-04

ApplicantEit Emerging Implant Technologies GmbH
Decision Date2019-02-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EIT Cellular Titanium Lumbar Cage - T/PLIF is a medical device manufactured by Eit Emerging Implant Technologies GmbH. It received FDA 510(k) clearance on 2019-02-04 under approval number K183447. 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 - T/PLIF?

EIT Cellular Titanium Lumbar Cage - T/PLIF is a medical device that received FDA 510(k) clearance on 2019-02-04. It is manufactured by Eit Emerging Implant Technologies GmbH. The 510(k) number is K183447.

When was EIT Cellular Titanium Lumbar Cage - T/PLIF approved by the FDA?

EIT Cellular Titanium Lumbar Cage - T/PLIF received FDA 510(k) clearance on 2019-02-04, under approval number K183447.

What company makes EIT Cellular Titanium Lumbar Cage - T/PLIF?

EIT Cellular Titanium Lumbar Cage - T/PLIF is manufactured by Eit Emerging Implant Technologies GmbH.

What is the FDA product code for EIT Cellular Titanium Lumbar Cage - T/PLIF?

The FDA product code for EIT Cellular Titanium Lumbar Cage - T/PLIF is MAX.

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Eit Emerging Implant Technologies GmbH

K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages K181644EIT Cellular Titanium® Lumbar Cage LLIF K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.

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