www.fdanews.com/articles/204345-intelivation-gets-fdas-510k-clearance-for-cervical-interbody-fusion-device
Intelivation Gets FDA’s 510(k) Clearance for Cervical Interbody Fusion Device
September 10, 2021
Intelivation Technologies has received the FDA’s 510(k) clearance for its Advantage-C PEEK (polyether ether ketone) cervical interbody fusion device.
Advantage-C is designed to be used in skeletally mature patients in conjunction with fixation for anterior cervical discectomy and fusion procedures for removal of herniated or degenerative discs in the neck.
The Saint Simons Island, Ga.-based company said it designed the device to “optimize fusion, while maintaining elasticity that is similar to bone and radiolucency of the cage body.”