FDA clears Spinal Elements' line of expandable interbody devices: 5 notes

Spinal Tech

The FDA approved Carlsbad, Calif.-based Spinal Elements' expandable interbody fusion devices.

Here are five notes:


1. The clearance encompasses expandable interbody devices for posterior, anterior and lateral access to the lumbar spine.


2. Spinal Elements makes the devices with PEEK and include the company's Ti-Bond porous titanium coating at the endplate contacting surfaces.

3. Spinal Elements' president commented these devices will enhance the company's posterior MIS solutions.


4. Clinical procedures with these expandable devices will occur later in 2016.


5. Spinal Elements expects an initial launch of these devices in early 2017.


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