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FDA 510(k)

Atlas Spine Lateral Expandable Interbody System

K-Number: K243191 · 2024-11-26

ApplicantAtlas Spine, Inc.
Decision Date2024-11-26
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine Lateral Expandable 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 2024-11-26 under 510(k) number K243191. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlas Spine Lateral Expandable Interbody System?

Atlas Spine Lateral Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K243191.

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

Atlas Spine Lateral Expandable Interbody System received FDA 510(k) clearance on 2024-11-26, under 510(k) number K243191.

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

The FDA product code for Atlas Spine Lateral Expandable Interbody System is OVD.

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 SystemK202302Atlas Spine Rebar (Ti) Spacer SystemK192570Atlas Spine Expandable Cervical Standalone Interbody SystemK182418V3 Segmental Plating System

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Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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