Atlas Spine HiRISE Expandable Cervical Corpectomy System— 510(k) K252560

Name: FDA 510(k) clearance K252560
Creator: U.S. Food and Drug Administration
Published: 2025-11-10

Substantially Equivalent

Atlas Spine, Inc.

FDA 510(k) clearance K252560 for Atlas Spine HiRISE Expandable Cervical Corpectomy System, Substantially Equivalent on 2025-11-10. Applicant: Atlas Spine, Inc.. Device class: 2.

Clearance details

Applicant: Atlas Spine, Inc.
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2025-08-13
Decision date: 2025-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jupiter, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLR

view all

K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant2026-07-15
K232481 — RIGEL 3DR Anterior Cervical Corpectomy System2023-10-13
K221542 — Galileo Vertebral Body Replacement Device2023-01-13
K212126 — MediExpand Cervical Expandable VBR System2022-04-04
K211320 — CAPRI Corpectomy Cage System2022-02-24

More clearances from Atlas Spine, Inc.

view all

K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System2025-08-15
K243191 — Atlas Spine Lateral Expandable Interbody System2024-11-26
K202302 — Atlas Spine Rebar (Ti) Spacer System2020-10-30
K192570 — Atlas Spine Expandable Cervical Standalone Interbody System2020-02-28
K182418 — V3 Segmental Plating System2018-11-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.