Aries® Lumbar Interbodies
K-Number: K181347 · 2018-08-15
ApplicantOsseus Fusion Systems, LLC
Decision Date2018-08-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Aries® Lumbar Interbodies is a medical device manufactured by Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2018-08-15 under approval number K181347. 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 Aries® Lumbar Interbodies?
Aries® Lumbar Interbodies is a medical device that received FDA 510(k) clearance on 2018-08-15. It is manufactured by Osseus Fusion Systems, LLC. The 510(k) number is K181347.
When was Aries® Lumbar Interbodies approved by the FDA?
Aries® Lumbar Interbodies received FDA 510(k) clearance on 2018-08-15, under approval number K181347.
What company makes Aries® Lumbar Interbodies?
Aries® Lumbar Interbodies is manufactured by Osseus Fusion Systems, LLC.
What is the FDA product code for Aries® Lumbar Interbodies?
The FDA product code for Aries® Lumbar Interbodies is MAX.
Other Devices by Osseus Fusion Systems, 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.