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HomePress ReleaseEIN PresswireFDA De Novo issued for the RJB Trajectory Guidance instrument for Spinal...

FDA De Novo issued for the RJB Trajectory Guidance instrument for Spinal Screw Placement from Ruthless Spine 7/14/2023


Ruthless Spine

RJB Trajectory Guidance for Lumbar Pedicle Screw placement

IRWINDALE, CALIFORNIA, UNITED STATES, July 21, 2023/EINPresswire.com/ — Ruthless Spine Declares FDA De Novo Clearance for RJB Trajectory Guidance Instrument for Spinal Pedicle Screw Placement

Ruthless Spine, a startup backbone surgical procedure options firm, introduced in the present day that it has acquired FDA De Novo clearance for the RJB Trajectory Guidance instrument for spinal pedicle screw placement. The RJB accuracy has been demonstrated to the FDA to be not more than 3 levels of accuracy in each Axial and Sagittal planes

The RJB Trajectory Guidance instrument is a surgical class two instrument that helps surgeons place pedicle screws with larger accuracy and precision in the “FreeHand Approach. The instrument is designed for use with any if not all pedicle screw techniques.

The RJB is an instrument unto itself thus no further tools or individuals are required in the working room. Pre-Planning might be completed off of MRI Ruthless Spine Declares FDA De Novo Clearance for RJB Trajectory Guidance Instrument for Spinal Pedicle Screw Placement

Ruthless Spine, a startup backbone surgical procedure options firm, introduced in the present day that it has acquired FDA De Novo clearance for the RJB Trajectory Guidance instrument for spinal pedicle screw placement.

The RJB Trajectory Guidance instrument is a surgical class two instrument that helps surgeons place pedicle screws with larger accuracy and precision. The instrument is designed for use with any if not all pedicle screw techniques.

“We’re thrilled to obtain FDA clearance for the RJB Trajectory Guidance instrument,” stated Dr. Shane Pak, CEO and co-founder of Ruthless Spine. “This can be a important milestone for our firm, and we consider this expertise has the potential to revolutionize the approach pedicle screw placement is carried out.”

The RJB Trajectory Guidance instrument is the first addition to Ruthless Spine’s portfolio of backbone surgical procedure options. The corporate’s RJB Trajectory Guidance instrument is gravity primarily based not picture primarily based giving it many benefits over conventional picture primarily based steering.

“At Ruthless Spine, our mission is to develop progressive options that support surgeons in doing what they’re educated to do with larger velocity, accuracy with decrease radiatiation publicity,” stated Dr. Pak. “We’re dedicated to bringing new and higher options to market, and the RJB Trajectory Guidance instrument is a main instance of that dedication.”

About Ruthless Spine

Ruthless Spine is a privately held firm headquartered in Irwindale, CA. The corporate is devoted to growing backbone surgical procedure options that enhance affected person outcomes by aiding the surgeon with devices that assist information the outcomes. For extra info, please go to www.ruthlessspine.com.

“We’re thrilled to obtain FDA clearance for the RJB . y Guidance instrument,” stated Dr. Shane Pak, CEO and co-founder of Ruthless Spine. “This can be a important milestone for our firm, and we consider this expertise has the potential to revolutionize the approach pedicle screw placement is carried out.” The RJB Trajectory Guidance instrument is the first addition to Ruthless Spine’s portfolio of backbone surgical procedure options.

“At Ruthless Spine, our mission is to develop progressive options that enhance the surgical accuracy of spinal surgeons,” stated Dr. Pak. “We’re dedicated to bringing new and higher options to market, and the RJB Trajectory Guidance instrument is a main instance of that dedication.”

About Ruthless Spine

Ruthless Spine is a privately held firm headquartered in Irwindale, CA. The corporate is devoted to growing backbone surgical procedure options that enhance affected person outcomes and high quality of life. Ruthless Spine’s merchandise hopefully can be utilized by main backbone surgeons round the world. For extra info, please go to www.ruthlessspine.com.

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