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Spinal Resources receives FDA 510(k) clearance for new pedicle screw system

September 8, 2017

The Swedge Pedicle Screw System received FDA 510(k) clearance to be used with a 5.5-mm rod, according to an announcement from Spinal Resources Inc., which manufactures the system.

The Swedge system includes cobalt-chromium and titanium tulips; double-lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws; and options that allow for minimally invasive spine surgery, according to a press release. FDA clearance to use 4.75-mm and 5-mm rods with the Swedge Pedicle Screw System is pending, according to the release.

K2M receives FDA clearance, CE mark for proximal fixation spinal system

July 6, 2017
K2M Group Holdings Inc. announced it has received FDA 510(k) clearance and a CE mark for the NILE proximal fixation spinal system, which is designed for proximal…
VideoFrom OT Europe

VIDEO: Pedicle subtraction osteotomy in degenerative scoliosis

July 5, 2017
In this video from the Open Operating Theatre, Rune Hedlund MD, from Sahlgrenska University Hospital in Gothenburg, Sweden, discusses how to perform a pedicle…
In the Journals

Study explores image guidance based on MRI for spinal interstitial laser thermotherapy

June 15, 2017
Results from this study demonstrated image guidance based on MRI for laser interstitial thermotherapy of a spinal metastasis was viable. Researchers retrospectively…
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