Ruthless Spine
RJB Trajectory Guidance for Lumbar Pedicle Screw placement
IRWINDALE, CALIFORNIA, UNITED STATES, July 21, 2023/EINPresswire.com/ — Ruthless Spine Announces FDA De Novo Clearance for RJB Trajectory Guidance Instrument for Spinal Pedicle Screw Placement
Ruthless Spine, a startup spine surgery solutions company, announced today that it has received 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 no more than 3 degrees of accuracy in both Axial and Sagittal planes
The RJB Trajectory Guidance instrument is a surgical class two instrument that helps surgeons place pedicle screws with greater accuracy and precision in the “FreeHand Technique. The instrument is designed to be used with any if not all pedicle screw systems.
The RJB is an instrument unto itself thus no extra equipment or people are required in the operating room. Pre-Planning can be done off of MRI Ruthless Spine Announces FDA De Novo Clearance for RJB Trajectory Guidance Instrument for Spinal Pedicle Screw Placement
Ruthless Spine, a startup spine surgery solutions company, announced today that it has received 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 greater accuracy and precision. The instrument is designed to be used with any if not all pedicle screw systems.
“We are thrilled to receive FDA clearance for the RJB Trajectory Guidance instrument,” said Dr. Shane Pak, CEO and co-founder of Ruthless Spine. “This is a significant milestone for our company, and we believe this technology has the potential to revolutionize the way pedicle screw placement is performed.”
The RJB Trajectory Guidance instrument is the first addition to Ruthless Spine’s portfolio of spine surgery solutions. The company’s RJB Trajectory Guidance instrument is gravity based not image based giving it many advantages over traditional image based guidance.
“At Ruthless Spine, our mission is to develop innovative solutions that aid surgeons in doing what they are trained to do with greater speed, accuracy with lower radiatiation exposure,” said Dr. Pak. “We are committed to bringing new and better solutions to market, and the RJB Trajectory Guidance instrument is a prime example of that commitment.”
About Ruthless Spine
Ruthless Spine is a privately held company headquartered in Irwindale, CA. The company is dedicated to developing spine surgery solutions that improve patient outcomes by aiding the surgeon with instruments that help guide the results. For more information, please visit www.ruthlessspine.com.
“We are thrilled to receive FDA clearance for the RJB . y Guidance instrument,” said Dr. Shane Pak, CEO and co-founder of Ruthless Spine. “This is a significant milestone for our company, and we believe this technology has the potential to revolutionize the way pedicle screw placement is performed.” The RJB Trajectory Guidance instrument is the first addition to Ruthless Spine’s portfolio of spine surgery solutions.
“At Ruthless Spine, our mission is to develop innovative solutions that improve the surgical accuracy of spinal surgeons,” said Dr. Pak. “We are committed to bringing new and better solutions to market, and the RJB Trajectory Guidance instrument is a prime example of that commitment.”
About Ruthless Spine
Ruthless Spine is a privately held company headquartered in Irwindale, CA. The company is dedicated to developing spine surgery solutions that improve patient outcomes and quality of life. Ruthless Spine’s products hopefully will be used by leading spine surgeons around the world. For more information, please visit www.ruthlessspine.com.
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