Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant— 510(k) K252822

Name: FDA 510(k) clearance K252822
Creator: U.S. Food and Drug Administration
Published: 2026-07-15

Substantially Equivalent

Atlas Spine, Inc.

FDA 510(k) clearance K252822 for Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant, Substantially Equivalent on 2026-07-15. Applicant: Atlas Spine, Inc.. Device class: 2.

Summary

Atlas Spine's HiRISE Expandable Cervical-p Corpectomy Implant is filed under PLR, cervical spinal vertebral body replacement devices. The record doesn't give sizes or materials.

Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).

Atlas Spine filed from Jupiter, Florida. Review took 314 calendar days (September 4, 2025 to July 15, 2026).

Clearance details

Applicant: Atlas Spine, Inc.
Product code: Product code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2025-09-04
Decision date: 2026-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jupiter, FL, US

Download summary PDF View on FDA.gov ↗

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K192570 — Atlas Spine Expandable Cervical Standalone Interbody System2020-02-28
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Data sourced from openFDA. This site is unofficial and independent of the FDA.