Home / 510(k) Clearances / K252560

510(k) K252560

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System by Atlas Spine, Inc. — Product Code PLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2025
Date Received
August 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device - Cervical
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Vertebral body replacement in the cervical spine.

Other clearances by Atlas Spine, Inc.

  • K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System (August 15, 2025)
  • K243191 — Atlas Spine Lateral Expandable Interbody System (November 26, 2024)
  • 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 PLR

  • K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy System (October 13, 2023)
  • K221542 — Galileo Vertebral Body Replacement Device (January 13, 2023)
  • K212126 — MediExpand Cervical Expandable VBR System (April 4, 2022)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K192145 — Galileo Vertebral Body Replacement Device (April 21, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K190284 — Bengal Stackable Cage System (December 20, 2019)
  • K190426 — ALTA Anterior Cervical Corpectomy System (October 24, 2019)
  • K191778 — Omnia Medical VBR (August 28, 2019)
  • K191423 — Normandy VBR System (August 6, 2019)