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FDA 510(k)

Atlas Spine Expandable Cervical Standalone Interbody System

K-Number: K192570 · 2020-02-28

ApplicantAtlas Spine, Inc.
Decision Date2020-02-28
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine Expandable Cervical Standalone Interbody System is a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2020-02-28 under approval number K192570. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlas Spine Expandable Cervical Standalone Interbody System?

Atlas Spine Expandable Cervical Standalone Interbody System is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K192570.

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

Atlas Spine Expandable Cervical Standalone Interbody System received FDA 510(k) clearance on 2020-02-28, under approval number K192570.

What company makes Atlas Spine Expandable Cervical Standalone Interbody System?

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

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

The FDA product code for Atlas Spine Expandable Cervical Standalone Interbody System is OVE.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED 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 K243191Atlas Spine Lateral Expandable Interbody System

View all 9 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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