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.

Clearance details

Applicant: SpineCraft
Product code: 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 ↗

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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

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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.