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Eminent Spine 3D Cervical Interbody Fusion System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212701

by Eminent Spine

Identifiers

510(k) Number
K212701 FDA 510(k)
FDA Product Code
ODP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Eminent Spine 3D Cervical Interbody Fusion System is a device indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease of the cervical spine at one disc level from C2-C3 to C7-T1. It is designed to provide structural support and facilitate bone growth between adjacent vertebral bodies.

The system is supplied as a sterile, single-use implant system composed of various sizes and configurations to accommodate individual patient anatomy. It has received FDA 510(k) clearance under K number K212701 and product code ODP, and is intended for use in cervical spinal fusion procedures.

Frequently asked questions

What is the Eminent Spine 3D Cervical Interbody Fusion System used for?

It is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease of the cervical spine at one disc level from C2-C3 to C7-T1, providing structural support and facilitating bone growth between adjacent vertebral bodies.

How is the Eminent Spine 3D Cervical Interbody Fusion System supplied and is it reusable?

The system is supplied as a sterile, single-use implant system composed of various sizes and configurations to accommodate individual patient anatomy, meaning it is intended for one-time use only and not designed for reuse.

What regulatory clearance does the Eminent Spine 3D Cervical Interbody Fusion System have?

It has received FDA 510(k) clearance under K number K212701 and product code ODP, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cervical Implants | Eminent Spine, Spinal Products You Can Count On | Eminent Spine, Eminent Spine 3D Cervical Interbody Fusion System, K212701 FDA 510(k) - Eminent Spine 3D Cervical Interbody Fus...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eminent Spine

Sources (1)

  • FDA 510(k) K212701 24 fields · synced Sep 22, 2026