FDA Clears Eden Spine’s Lumbar Spine Locking Plate

The FDA granted 510(k) approval to Eden Spine’s Sphynx, a thoraco lumbar spine locking plate used for spine instabilities.

The device, which is made titanium, is implanted via the antero-lateral approach and is used to treat instabilities in the thoraco-lumbar regions of the spine.

Sphynx’s indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and other indications requiring an anterior stabilization low profile.