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FDA 510(k)

Xsert Lumbar Expandable Interbody System

K-Number: K160959 · 2016-11-17

ApplicantX-Spine Systems, Inc.
Decision Date2016-11-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xsert Lumbar Expandable Interbody System is a medical device manufactured by X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-11-17 under approval number K160959. 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 Xsert Lumbar Expandable Interbody System?

Xsert Lumbar Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by X-Spine Systems, Inc.. The 510(k) number is K160959.

When was Xsert Lumbar Expandable Interbody System approved by the FDA?

Xsert Lumbar Expandable Interbody System received FDA 510(k) clearance on 2016-11-17, under approval number K160959.

What company makes Xsert Lumbar Expandable Interbody System?

Xsert Lumbar Expandable Interbody System is manufactured by X-Spine Systems, Inc..

What is the FDA product code for Xsert Lumbar Expandable Interbody System?

The FDA product code for Xsert Lumbar 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 NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by X-Spine Systems, Inc.

K162944Irix-C Cervical Integrated Fusion System K160428Certex Spinal Fixation System K160114Xspan Laminoplasty Fixation System K170119Calix Lumbar Spinal Implant System K171567IRIX-A Lumbar Integrated Fusion System K171075Calix-C Cervical Interbody Spacer

View all 11 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. K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC

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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