Minimally Invasive Surgery

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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.

FDA grants K2M 510(k) clearance for 3-D-printed corpectomy cage

June 28, 2017
K2M Group Holdings Inc. has announced it received FDA 510(k) clearance for the CAPRI Small 3D Static Corpectomy Cage System, which is first-to-market and the first…

DePuy Synthes acquires Sentio

June 27, 2017
DePuy Synthes Products Inc. announced it has acquired Innovative Surgical Solutions LLC, doing business as Sentio LLC. Sentio markets nerve localization technology for…
In the Journals

Similar outcomes seen with mini-open corpectomy without fusion vs open instrumented fusion

May 22, 2017
Investigators found comparable implant failure and reoperation rates up to 2-year follow-up for minimally invasive corpectomy with percutaneously instrumented non-fused…
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