FDA 510(k)

Navagio Lumbar Cage

K-Number: K220902 · 2022-05-27

Decision Date2022-05-27

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Navagio Lumbar Cage is a medical device manufactured by Kalitec Medical, LLC. It received FDA 510(k) clearance on 2022-05-27 under approval number K220902. 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 Navagio Lumbar Cage?

Navagio Lumbar Cage is a medical device that received FDA 510(k) clearance on 2022-05-27. It is manufactured by Kalitec Medical, LLC. The 510(k) number is K220902.

When was Navagio Lumbar Cage approved by the FDA?

Navagio Lumbar Cage received FDA 510(k) clearance on 2022-05-27, under approval number K220902.

What company makes Navagio Lumbar Cage?

Navagio Lumbar Cage is manufactured by Kalitec Medical, LLC.

What is the FDA product code for Navagio Lumbar Cage?

The FDA product code for Navagio Lumbar Cage is MAX.

Other Devices by Kalitec Medical, LLC

K182210TiWAVE-L Porous Titanium Lumbar 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

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