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FDA 510(k)

Atlas Spine Lateral Expandable Interbody System

K-Number: K243191 · 2024-11-26

ApplicantAtlas Spine, Inc.
Decision Date2024-11-26
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine Lateral Expandable Interbody System is a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2024-11-26 under approval number K243191. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlas Spine Lateral Expandable Interbody System?

Atlas Spine Lateral Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2024-11-26. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K243191.

When was Atlas Spine Lateral Expandable Interbody System approved by the FDA?

Atlas Spine Lateral Expandable Interbody System received FDA 510(k) clearance on 2024-11-26, under approval number K243191.

What company makes Atlas Spine Lateral Expandable Interbody System?

Atlas Spine Lateral Expandable Interbody System is manufactured by Atlas Spine, Inc..

What is the FDA product code for Atlas Spine Lateral Expandable Interbody System?

The FDA product code for Atlas Spine Lateral Expandable Interbody System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Atlas Spine, Inc.

K172334Ortus™ Expandable Lumbar Interbody Fusion System K162918Atlas Spine Expandable Interbody System K182418V3 Segmental Plating System K180675Atlas Spine Expandable Cervical Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System

View all 9 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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