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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 the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) 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. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K192570.

When did Atlas Spine Expandable Cervical Standalone Interbody System receive FDA 510(k) clearance?

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

Who is the listed applicant for Atlas Spine Expandable Cervical Standalone 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 Expandable Cervical Standalone Interbody System?

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

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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Atlas Spine, Inc. as applicant

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantK252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemK251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemK243191Atlas Spine Lateral Expandable Interbody SystemK202302Atlas Spine Rebar (Ti) Spacer SystemK182418V3 Segmental Plating System

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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