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FDA 510(k)

X-Pac Expandable LLIF Cage System

K-Number: K223174 · 2023-02-14

ApplicantExpanding Innovations, Inc.
Decision Date2023-02-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-Pac Expandable LLIF Cage System is a medical device manufactured by Expanding Innovations, Inc.. It received FDA 510(k) clearance on 2023-02-14 under approval number K223174. 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 X-Pac Expandable LLIF Cage System?

X-Pac Expandable LLIF Cage System is a medical device that received FDA 510(k) clearance on 2023-02-14. It is manufactured by Expanding Innovations, Inc.. The 510(k) number is K223174.

When was X-Pac Expandable LLIF Cage System approved by the FDA?

X-Pac Expandable LLIF Cage System received FDA 510(k) clearance on 2023-02-14, under approval number K223174.

What company makes X-Pac Expandable LLIF Cage System?

X-Pac Expandable LLIF Cage System is manufactured by Expanding Innovations, Inc..

What is the FDA product code for X-Pac Expandable LLIF Cage System?

The FDA product code for X-Pac Expandable LLIF 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 Expanding Innovations, Inc.

K201145X-Pac Expandable Lumbar Cage System K203802X-Pac Expandable Lumbar Cage System K222797X-Pac Expandable Lumbar Cage System K220655X-Pac Expandable Lumbar Cage System K251003X-PAC® LLIF Expandable Lateral Cage System K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System

View all 8 devices →

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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