The hinge was designed to allow for a custom fit for each patient and reduce the need for the surgeon to bend the plate intraoperatively
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today the FDA 510(k) clearance of the Hinged Laminoplasty System.
“The laminoplasty procedure is an excellent alternative to a laminectomy. I am excited to continue to launch systems that are designed for less invasive procedures. The Hinged Laminoplasty System joins our portfolio of innovative Posterior Cervical solutions including the SOLSTICE® Occiptio-Cervico-Thoracic System complete with hooks, prebent rods, transition components, cross connectors and a Cranial Fusion Plate System,” said Mariusz Knap, Vice President of Marketing and Business Development.
A novel retaining screwdriver, which threads on to the screw head for a more secure and safe connection, and intuitive instrumentation are hallmarks of the system. Additionally, the hinge was designed to allow for a custom fit for each patient and reduce the need for the surgeon to bend the plate intraoperatively. The Hinged Laminoplasty system is Life Spine’s fifth 510(k) in 2019 and marks their 86th 510(k) since inception.
Source: Company Press Release