Hospitals

LinkSPINE Announces FDA (510)k Clearance of FacetLINK Fixation Platform

Rockaway, NJ – LinkSPINE, a company focused upon simple, less invasive implants and techniques for spinal surgery, is pleased to announce FDA (510)k Clearance of FacetLINK. FacetLINK uses two screws and a novel plated cross-connector assembly to stabilize the spine following a tissue-sparing midline or microsurgical decompression. The plate assemblies are available in numerous sizes as well as an expandable version to accommodate various anatomical and pathological scenarios, as well as surgeon preferences.

Christopher Chaput, MD, an Orthopaedic Spine Surgeon and Director of Orthopaedic Research at Baylor Scott and White in Temple, TX states, “FacetLINK provides me with an additional tool for treating cases with mild to moderate instability, where a less extensive exposure is desired. The ability to achieve bilateral fixation in these cases through the unilateral exposure I work through for my micro-decompression is an attractive feature to me.”

Faheem Sandhu, MD, Professor of Neurosurgery and Director of Spine Surgery at Medstar Georgetown Hospital in Washington, DC comments, “the FacetLINK platform offers the option to use a small implant that secures rigid biomechanical stability, but without the additional tissue exposure required to seat conventional pedicle screw and rod fixation. This is an attractive alternative for cases with mild to moderate instability.”

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