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FDA 510(k)

Atlas Spine Expandable Interbody System

K-Number: K162918 · 2017-02-09

ApplicantAtlas Spine, Inc.
Decision Date2017-02-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine Expandable Interbody System is a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2017-02-09 under approval number K162918. 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 Expandable Interbody System?

Atlas Spine Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K162918.

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

Atlas Spine Expandable Interbody System received FDA 510(k) clearance on 2017-02-09, under approval number K162918.

What company makes Atlas Spine Expandable Interbody System?

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

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

The FDA product code for Atlas Spine 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 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 NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Other Devices by Atlas Spine, Inc.

K172334Ortus™ Expandable Lumbar Interbody Fusion System K182418V3 Segmental Plating System K180675Atlas Spine Expandable Cervical Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System K243191Atlas Spine Lateral Expandable Interbody System

View all 9 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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