OMEGA21 Spinal Fixation System

No FDA recalls on record, checked 22 Oct 2026.

Full name

Ebi OMEGA21 Spinal Fixation System

510(k) Number

K031354 ↗

FDA Product Code

MNI

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modification to Ebi Xfix Dfs System

  Class II

  FDA 510(k) K023324 Active Cleared 18 Oct 2002

• Ebi Vuelock Anterior Cervical Plate System

  Class II

  FDA 510(k) K023133 Active Cleared 18 Oct 2002

• Ebi Spinelink - II Spinal Fixation System

  Class II

  FDA 510(k) K031355 Active Cleared 22 Jul 2003

• Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System

  Class II

  FDA 510(k) K032390 Active Cleared 29 Aug 2003

• Array Spinal System Line Extension

  Class II

  FDA 510(k) K061978 Active Cleared 11 Aug 2006

• Ebi P148 Spinal Fixation System

  Class II

  FDA 510(k) K031423 Active Cleared 27 Jun 2003

See all devices from Ebi, L.P. →

• What types of spinal conditions is the Omega21 Spinal Fixation System designed to address in clinical practice?

  The Omega21 Spinal Fixation System is specifically designed for non-cervical spinal stabilization, targeting the thoracic, lumbar, and sacral regions. It is intended for surgical use by orthopedic surgeons to address spinal pathologies such as degenerative disc disease, trauma, or deformities that require rigid mechanical support.

• Is the Omega21 Spinal Fixation System intended for single-use or can it be reused after surgery?

  The Omega21 Spinal Fixation System is explicitly supplied as a reusable device. This means it is engineered to withstand multiple surgical procedures, reducing the need for disposable components and contributing to cost efficiency in clinical settings.

• How was the FDA clearance for the Omega21 Spinal Fixation System determined, and what does this mean for its regulatory status?

  The Omega21 received FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets applicable safety and effectiveness standards for Class 2 Orthopedic spinal fixation devices.

• What components are included in the Omega21 Spinal Fixation System, and how do they contribute to spinal stabilization?

  The system includes rods, screws, couplers, and hooks, all of which work together to provide rigid mechanical support to the spine. The rods act as the primary structural element, while screws and hooks anchor the system to the vertebrae, and couplers allow for modular assembly to accommodate varying spinal anatomies and surgical needs.

• What does the product code 'MNI' indicate about the regulatory classification and intended use of the Omega21 Spinal Fixation System?

  The product code 'MNI' categorizes the Omega21 Spinal Fixation System under the FDA’s classification system for orthopedic devices. It specifically falls under the 'Musculoskeletal, Non-Articular' category, confirming its use for spinal stabilization in non-cervical regions (thoracic, lumbar, and sacral) rather than joint-related applications or cervical spine procedures.