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6 important government approvals for your practice
Spine Surgery Today has highlighted six stories of drugs and devices receiving government approval to keep your practice up-to-date.
Simplify cervical artificial disc receives IDE approval
Simplify Medical recently announced it has received Investigational Device Exemption from the FDA for its Simplify cervical artificial disc. Read more.
Stryker Spine receives FDA clearance for new plating system
Stryker Corporation’s Spine Division recently announced it has received 510(k) clearance from the FDA for the LITe Plate System, an anterior and lateral lumbar plate system. Read more.
SpineGuard receives FDA clearance to market pedicle screw system
SpineGuard recently announced it has received 510(k) clearance from the FDA to market its PediGuard product line for minimally invasive surgery. Read more.
ECA Medical receives FDA approval for disposable spine implant system
ECA Medical Instruments has developed the industry’s first fully disposable spine implant fixation instrument kit to gain FDA approval, according to a company press release. Read more.
Amedica first to receive FDA clearance for multi-level cervical treatment
Amedica Corporation recently announced that the FDA has expanded the indications for the company’s silicon nitride interbody fusion products to include multi-level cervical treatment. Read more.
Titan issued FDA clearance to launch cervical fusion offering
Titan Spine recently announced it has received 510(k) clearance from the FDA to commercially release its Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation. Read more.