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510(k) K180675

Atlas Spine Expandable Cervical Interbody System by Atlas Spine, Inc. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2018
Date Received
March 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Atlas Spine, Inc.

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  • K192570 — Atlas Spine Expandable Cervical Standalone Interbody System (February 28, 2020)
  • K182418 — V3 Segmental Plating System (November 29, 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)

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  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
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  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)