FDA 510(k)

Atlas Spine Project X Expandable Posterior Lumbar Interbody System

K-Number: K251969 · 2025-08-15

Decision Date2025-08-15

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251969. 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 Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K251969.

When did Atlas Spine Project X Expandable Posterior Lumbar Interbody System receive FDA 510(k) clearance?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251969.

Who is the listed applicant for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

The FDA 510(k) record lists Atlas Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

The FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITING NCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITING NCT06820736A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And FusionRECRUITING NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING NCT07327554Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After RehabilitationRECRUITING

Other records listing Atlas Spine, Inc. as applicant

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy System K243191Atlas Spine Lateral Expandable Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System K182418V3 Segmental Plating System

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Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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.