Nexxt Matrixx System
K-Number: K191408 · 2019-07-10
ApplicantNexxt Spine, LLC
Decision Date2019-07-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Nexxt Matrixx System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2019-07-10 under approval number K191408. 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 Nexxt Matrixx System?
Nexxt Matrixx System is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K191408.
When was Nexxt Matrixx System approved by the FDA?
Nexxt Matrixx System received FDA 510(k) clearance on 2019-07-10, under approval number K191408.
What company makes Nexxt Matrixx System?
Nexxt Matrixx System is manufactured by Nexxt Spine, LLC.
What is the FDA product code for Nexxt Matrixx System?
The FDA product code for Nexxt Matrixx System is MAX.
Other Devices by Nexxt Spine, LLC
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.