ORIO-3D Cage System— 510(k) K253260

Name: FDA 510(k) clearance K253260
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

SpineCraft

FDA 510(k) clearance K253260 for ORIO-3D Cage System, Substantially Equivalent on 2026-04-16. Applicant: SpineCraft. Device class: 2.

Summary

SpineCraft's ORIO-3D Cage System is filed under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Class II, 21 CFR 888.3080. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

SpineCraft filed from Westmont, Illinois. Review took 199 calendar days (September 29, 2025 to April 16, 2026).

Clearance details

Applicant: SpineCraft
Product code: Product code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-09-29
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from SpineCraft

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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