Tag: US FDA APPROVAL

Sphynx

FDA approval granted for Eden Spine’s Sphynx

Eden Spine’s Sphynx plating system has been granted FDA clearance, the company has announced. Sphynx was designed to complement the company’s Giza titanium vertebral body...
NuVasive

NuVasive unveils spine’s first integrated surgical automation platform

NuVasive has announced the Pulse surgical automation platform has received 510(k) clearance from the US Food and Drug Administration (FDA). Pulse is the foundation...
nanotechnology

FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion

The US Food and Drug Administration (FDA) has granted approval to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface...
LifeSciences

FDA clearance granted for Hive-C cervical interbody devices

HD LifeSciences has received FDA 510(k) clearance for its Hive-C IBFD, a system of interbody devices for anterior cervical fusion procedures. The Hive-C implant system...
Tesera

Renovis Surgical receives FDA clearance for Tesera Trabecular Technology Hyperlordotic ALIF...

  Renovis Surgical Technologies has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SA...

First patented single implant sacroiliac joint fusion system receives FDA clearance

The US Food and Drug Administration (FDA) have granted clearance for the Catamaran sacroiliac joint fixation system (Tenon Medical) specifically indicated for sacroiliac joint...

Bone cement solution indicated for treating sacral fractures granted FDA approval

The US Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon HV-R bone cement (Medtronic) for fixation of pathological fractures of the...