Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System

K-Number: K252560 · 2025-11-10

ApplicantAtlas Spine, Inc.
Decision Date2025-11-10
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-11-10 under 510(k) number K252560. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atlas Spine HiRISE™ Expandable Cervical Corpectomy System?

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K252560.

When did Atlas Spine HiRISE™ Expandable Cervical Corpectomy System receive FDA 510(k) clearance?

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252560.

Who is the listed applicant for Atlas Spine HiRISE™ Expandable Cervical Corpectomy System?

The FDA 510(k) record lists Atlas Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlas Spine HiRISE™ Expandable Cervical Corpectomy System?

The FDA product code for Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is PLR.

Other records listing Atlas Spine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantK251969Atlas Spine Project X Expandable Posterior Lumbar Interbody SystemK243191Atlas Spine Lateral Expandable Interbody SystemK202302Atlas Spine Rebar (Ti) Spacer SystemK192570Atlas Spine Expandable Cervical Standalone Interbody SystemK182418V3 Segmental Plating System

View all 10 devices →

Related Devices (Code: PLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, Inc.K192145Galileo Vertebral Body Replacement DeviceBright Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑