Decision Date2021-08-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
BEE PLIF Cage is a medical device manufactured by NGMedical GmbH. It received FDA 510(k) clearance on 2021-08-27 under approval number K211413. 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 BEE PLIF Cage?
BEE PLIF Cage is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by NGMedical GmbH. The 510(k) number is K211413.
When was BEE PLIF Cage approved by the FDA?
BEE PLIF Cage received FDA 510(k) clearance on 2021-08-27, under approval number K211413.
What company makes BEE PLIF Cage?
BEE PLIF Cage is manufactured by NGMedical GmbH.
What is the FDA product code for BEE PLIF Cage?
The FDA product code for BEE PLIF 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.