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.
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