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FDA 510(k)

ABTross ALIF Expandable Cage System

K-Number: K221719 · 2022-11-03

ApplicantAegis Spine, Inc.
Decision Date2022-11-03
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABTross ALIF Expandable Cage System is a medical device manufactured by Aegis Spine, Inc.. It received FDA 510(k) clearance on 2022-11-03 under approval number K221719. 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 ABTross ALIF Expandable Cage System?

ABTross ALIF Expandable Cage System is a medical device that received FDA 510(k) clearance on 2022-11-03. It is manufactured by Aegis Spine, Inc.. The 510(k) number is K221719.

When was ABTross ALIF Expandable Cage System approved by the FDA?

ABTross ALIF Expandable Cage System received FDA 510(k) clearance on 2022-11-03, under approval number K221719.

What company makes ABTross ALIF Expandable Cage System?

ABTross ALIF Expandable Cage System is manufactured by Aegis Spine, Inc..

What is the FDA product code for ABTross ALIF Expandable Cage System?

The FDA product code for ABTross ALIF Expandable Cage System is MAX.

Related Clinical Trials

NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

Other Devices by Aegis Spine, Inc.

K203531XYPAN Expandable Lumbar Cage System K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System K223521ZESPIN SI Joint Fusion System K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

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.

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