Regulatory

Articles

June 21, 2022

Altus Spine Granted FDA Clearance for Sochi OCT System

Altus Spine Granted FDA Clearance for Sochi OCT System
Comprising polyaxial screws, hooks, rods, locking screw assemblies and connectors, Sochi OCT may be rigidly locked to promote fusion for a variety of anatomies.
June 14, 2022

Xenco Medical Expands ASC Device Portfolio

Xenco Medical Expands ASC Device Portfolio
Xenco announced FDA clearance and launch of its Multilevel CerviKit, implants and single-use instruments for 2, 3 and 4 level anterior cervical spine procedures.
May 31, 2022

SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite

SI-BONE Gains FDA 510(k) for iFuse Bedrock Granite
The Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundation for segmental spinal fusion procedures.
May 18, 2022

CTL Amedica Navigation Instrument System Gains FDA 510(k)

CTL Amedica Navigation Instrument System Gains FDA 510(k)
The system features instruments adaptable for use with third-party navigation to locate anatomical structures for placement of pedicle screws.