Wenzel Spine Receives FDA Clearance Expanding Clinical Indications for primaLOK SP

AUSTIN, Texas, August 22, 2023–(BUSINESS WIRE)–Wenzel Backbone, Inc., a medical expertise firm specializing within the growth of a minimally invasive surgical expertise and diagnostic platform for the therapy of spinal issues, is happy to announce the latest FDA clearance for his or her primaLOK SP System. This achievement marks a major development in spinal fusion expertise, providing surgeons and sufferers a extremely efficient and dependable resolution for spinal stabilization.

The primaLOK SP System combines cutting-edge engineering with patient-focused design to supply a complete resolution for spinal fusion procedures. With this clearance, Wenzel Backbone continues its dedication to delivering high-quality merchandise that improve surgical outcomes and enhance affected person lives. The brand new scientific indications from the FDA clearance enable for the primaLOK SP for use at a number of ranges and to deal with sufferers with lumbar spinal stenosis.

“We’re proud to obtain FDA clearance to replace the scientific indications for primaLOK SP. This achievement displays our ongoing dedication to innovation and excellence in our spinal options. We consider this method will considerably contribute to improved affected person outcomes by a much less invasive strategy,” commented, William E. Wilson, CEO of Wenzel Backbone.

Key options and advantages of the primaLOK SP System embrace:

1. Revolutionary Locking Mechanism: The primaLOK SP System boasts a singular locking mechanism that ensures safe stabilization, lowering the chance of migration and offering stability throughout the essential fusion course of.

2. Precision and Versatility: Engineered with precision, the distinctive polyaxial primaLOK SP System presents a excessive diploma of flexibility to accommodate varied affected person anatomies and presents surgeons the flexibility to tailor every process to particular person wants.

3. Minimized Tissue Disruption: The system’s minimally invasive strategy minimizes tissue disruption, doubtlessly resulting in decreased postoperative ache, shorter hospital stays, and faster affected person restoration.

4. Enhanced Radiographic Visibility: The system design prioritizes enhanced radiographic visibility, permitting surgeons to confidently assess implant placement and fusion progress.

Dr. Charles Gordon, MD, a famend neurosurgeon and founding father of Texas Backbone & Joint Hospital in Tyler, TX, acknowledged, “The primaLOK SP System is a major development for spinal fusion procedures. Its versatile locking mechanism and patient-centric design actually set it aside. These expanded scientific indications will enable me to additional incorporate this method into my apply and supply my sufferers with a better degree of care.”

The clearance of the primaLOK SP System marks a milestone for Wenzel Backbone, underscoring their dedication to advancing spinal healthcare and reworking the panorama of spinal fusion procedures. primaLOK SP is commercially out there within the US.

For extra details about the primaLOK SP System and different groundbreaking procedural options from Wenzel Backbone, please go to their web site at www.wenzelspine.com.

About Wenzel Backbone:

Wenzel Backbone, Inc. is a medical expertise firm centered on offering minimally invasive options for the therapy of spinal issues. Headquartered in Austin, TX, Wenzel Backbone is targeted on delivering surgical options that enhance the general high quality of spine care by simplifying procedures and lowering restoration time. Wenzel Backbone seeks to enhance affected person high quality of life by designing and producing units of the very best high quality to help our surgeon shoppers within the care and therapy of their sufferers.