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 a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-08-15 under approval 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. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K251969.

When was Atlas Spine Project X Expandable Posterior Lumbar Interbody System approved by the FDA?

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

What company makes Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is manufactured by Atlas Spine, Inc..

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) 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

Related PubMed Literature

PMID: 42119715 Integrated chemical and molecular authentication of Pinellia tuber: A multinational collaboration within the FHH ATLAS project with government regulatory agencies from seven countries and regions. Fitoterapia (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.