510(k) K243191

Atlas Spine Lateral Expandable Interbody System by Atlas Spine, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 26, 2024
Date Received: September 30, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Atlas Spine, Inc.

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K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System (August 15, 2025)
K202302 — Atlas Spine Rebar (Ti) Spacer System (October 30, 2020)
K192570 — Atlas Spine Expandable Cervical Standalone Interbody System (February 28, 2020)
K182418 — V3 Segmental Plating System (November 29, 2018)
K180675 — Atlas Spine Expandable Cervical Interbody System (June 13, 2018)
K172334 — Ortus Expandable Lumbar Interbody Fusion System (October 25, 2017)
K162918 — Atlas Spine Expandable Interbody System (February 9, 2017)
K112759 — APCLO PEDICLE SCREW SYSTEMS (October 18, 2011)
K110842 — ATLAS SPINE PEDICLE SCREW SYSTEM (July 13, 2011)

Other clearances for product code OVD

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K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)