FDA 510(k)

Atlas Spine HiRISE Expandable Cervical Corpectomy System

K-Number: K252560 · 2025-11-10

Decision Date2025-11-10

Product CodePLR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Atlas Spine HiRISE Expandable Cervical Corpectomy System is a medical device manufactured by Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-11-10 under approval 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. It is manufactured by Atlas Spine, Inc.. The 510(k) number is K252560.

When was Atlas Spine HiRISE Expandable Cervical Corpectomy System approved by the FDA?

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

What company makes Atlas Spine HiRISE Expandable Cervical Corpectomy System?

Atlas Spine HiRISE Expandable Cervical Corpectomy System is manufactured by Atlas Spine, Inc..

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.

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Other Devices by Atlas Spine, Inc.

K172334Ortus Expandable Lumbar Interbody Fusion System K162918Atlas Spine Expandable Interbody System K182418V3 Segmental Plating System K180675Atlas Spine Expandable Cervical Interbody System K202302Atlas Spine Rebar (Ti) Spacer System K192570Atlas Spine Expandable Cervical Standalone Interbody System

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Related Devices (Code: PLR)

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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.