Paradigm Spine gets pre-market approval for disposable instrument kit: 4 things to know

Spinal Tech

Paradigm Spine received FDA pre-market approval for its coflex Interlaminar Stabilization disposable instrument kit.

Here are four things to know.

1. As Paradigm Spine's flagship product, coflex Interlaminar Stabilization is a posterior lumbar motion preservation for patients with moderate to severe spinal stenosis.

2. In the U.S., lumbar spinal stenosis affects 1.6 million patients annually.

3. The newly approved coflex disposable instrument kit will consist of a complete and simplified injection molded instruments set delivered in a pre-sterilized peel pack.

4. This is the first disposable spinal instrument set for a Class III spinal device to receive a supplemental PMA approval, which is the most stringent type of device marketing application required by the FDA.

More articles on devices and implants:

K2M's Q1 2018 revenue spikes to $67.9M, complex spine segment experiences 8% growth

Stryker, Zimmer Biomet, Medtronic & more: 11 device company notes

Zimmer Biomet presents new technology platform for spine business: 4 observations

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Webinars

Featured Whitepapers