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FDA 510(k)

ORIO-3D Cage System

K-Number: K253260 · 2026-04-16

ApplicantSpineCraft
Decision Date2026-04-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORIO-3D Cage System is a medical device manufactured by SpineCraft. It received FDA 510(k) clearance on 2026-04-16 under approval number K253260. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIO-3D Cage System?

ORIO-3D Cage System is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by SpineCraft. The 510(k) number is K253260.

When was ORIO-3D Cage System approved by the FDA?

ORIO-3D Cage System received FDA 510(k) clearance on 2026-04-16, under approval number K253260.

What company makes ORIO-3D Cage System?

ORIO-3D Cage System is manufactured by SpineCraft.

What is the FDA product code for ORIO-3D Cage System?

The FDA product code for ORIO-3D Cage System is ODP.

Other Devices by SpineCraft

K260015ANTERIS Thoracolumbar Plate System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

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