Decision Date2019-03-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Kuros TLIF Cage is a medical device manufactured by Kuros Biosciences B.V. It received FDA 510(k) clearance on 2019-03-08 under approval number K183092. 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 Kuros TLIF Cage?
Kuros TLIF Cage is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Kuros Biosciences B.V. The 510(k) number is K183092.
When was Kuros TLIF Cage approved by the FDA?
Kuros TLIF Cage received FDA 510(k) clearance on 2019-03-08, under approval number K183092.
What company makes Kuros TLIF Cage?
Kuros TLIF Cage is manufactured by Kuros Biosciences B.V.
What is the FDA product code for Kuros TLIF Cage?
The FDA product code for Kuros TLIF Cage is MAX.
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.