FDA 510(k)

AxCess® Expandable Interbody System

K-Number: K243739 · 2025-01-24

Decision Date2025-01-24

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AxCess® Expandable Interbody System is a medical device manufactured by Elliquence, LLC. It received FDA 510(k) clearance on 2025-01-24 under approval number K243739. 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 AxCess® Expandable Interbody System?

AxCess® Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2025-01-24. It is manufactured by Elliquence, LLC. The 510(k) number is K243739.

When was AxCess® Expandable Interbody System approved by the FDA?

AxCess® Expandable Interbody System received FDA 510(k) clearance on 2025-01-24, under approval number K243739.

What company makes AxCess® Expandable Interbody System?

AxCess® Expandable Interbody System is manufactured by Elliquence, LLC.

What is the FDA product code for AxCess® Expandable Interbody System?

The FDA product code for AxCess® Expandable Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

Other Devices by Elliquence, LLC

K160041Cobbra RF Tissue Dissector K170107Surgi Max Ultra K162490Disc-FX System K180766Endiscope, Endiscope Cervical

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.