Array Spinal System Line Extension
by Ebi, L.P. 510(k)
Active
510(k) K061978
Overview
The Array Spinal System Line Extension is a non-cervical spinal fixation device designed for mechanical stabilization of the spine. It includes pedicle screws, posterior hooks, sacral/iliac screws, and anterolateral fixation components to address conditions such as degenerative disc disease, trauma, deformity, tumor, stenosis, pseudarthrosis, and failed fusion.
This device is intended for use in clinical settings by surgeons and is classified under product code MNI as an orthopedic spinal fixation system. Authorized under FDA 510(k) clearance (K061978) with a decision of Substantially Equivalent (SESE), it falls under the regulatory classification of Orthosis, Spinal Pedicle Fixation. The device is reusable and intended for surgical application.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061978 | Date11 Aug 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Ebi, L.p.'s Line Extension to the Array Spinal System
- 510(k) Number
- FDA Product Code
- MNI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ebi, L.P.
Questions
What types of spinal conditions is this device designed to stabilize, and how does it achieve this?
The Array Spinal System Line Extension is specifically designed to mechanically stabilize the spine in non-cervical regions for conditions like degenerative disc disease, trauma, deformity, tumors, spinal stenosis, pseudarthrosis, and failed fusion surgeries. It achieves stabilization through a combination of pedicle screws, posterior hooks, sacral/iliac screws, and anterolateral fixation components, which work together to provide rigid support to the spine during healing or correction.
Is this device intended for single-use or can it be reused in multiple surgeries?
This device is explicitly designed as a reusable spinal fixation system. It is intended for surgical application and can be used across multiple procedures, provided it is properly cleaned, sterilized, and maintained between uses.
What clinical settings or professionals are authorized to use this device?
The Array Spinal System Line Extension is intended for use in clinical settings by qualified surgeons. It is not a self-administered device, and its application requires specialized training and surgical expertise to ensure proper placement and fixation of the spine.
How is this device categorized under regulatory standards, and what does that mean for its use?
This device falls under the FDA product code MNI, classified as an orthopedic spinal fixation system under the regulatory category of *Orthosis, Spinal Pedicle Fixation*. It was granted FDA 510(k) clearance (K061978) with a *Substantially Equivalent (SESE)* determination, meaning it meets the same performance criteria as a legally marketed predicate device. This classification ensures it adheres to strict safety and effectiveness standards for spinal stabilization procedures.