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FDA 510(k)

Atlas Spine Expandable Cervical Interbody System

K-Number: K180675 · 2018-06-13

ApplicantAtlas Spine, Inc.
Decision Date2018-06-13
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine Expandable Cervical Interbody System is a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2018-06-13 under approval number K180675. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlas Spine Expandable Cervical Interbody System?

Atlas Spine Expandable Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2018-06-13. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K180675.

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

Atlas Spine Expandable Cervical Interbody System received FDA 510(k) clearance on 2018-06-13, under approval number K180675.

What company makes Atlas Spine Expandable Cervical Interbody System?

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

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

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

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 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: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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