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Home » FDA clears CoreLink’s CentraFix midline fixation system

FDA clears CoreLink’s CentraFix midline fixation system

December 2, 2021 By Sean Whooley

CoreLink CenraFix Midline Fixation System
[Image from CoreLink]
CoreLink announced today that it won FDA 510(k) clearance for and commercially launched its CentraFix midline fixation system.

St. Louis-based CoreLink designed CentraFix as a posterior thoracolumbar pedicle screw for less invasive spinal fixation, often used with a medial-to-lateral approach known as cortical bone trajectory (CBT).

According to a news release, that technique allows for maximum contact of the pedicle screw with cortical bone with the aim of reducing incision size, limiting muscular and vascular injury and improving initial fixation.

CentraFix also features modular cobalt chrome tulip heads and titanium alloy screw shanks in various lengths and diameters for allowing screw placement in denser cortical bone, CoreLink said. he tulip heads minimize tissue disruption and simplify distraction without compromising strength.

“The CentraFix System provides unmatched intraoperative visualization and surgical flexibility for the midline approach,” CoreLink CEO Jay Bartling said in the release. “Our in-house development and manufacturing have allowed us to produce our most innovative fixation system to date.”

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance, Spine Tagged With: CoreLink, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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