NuVasive Grows Cervical Spinal Interbody Portfolio With ... | 合法醫療器材資訊網

2018年12月10日—...amodularPEEKinterbodysolutionforcervicalcorpectomyprocedures....TheMonolithcageisconstructedentirelyfromPEEKandincludes ...

Company receives FDA 510(k) clearance for expanded use of Monolith® Corpectomy System, introducing fully modular PEEK implant indicated for use in the cervical spine

SAN DIEGO – December 10, 2018 – NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith® Corpectomy System, providing surgeons with a modular PEEK interbody solution for cervical corpectomy procedures.

The FDA 510(k) indications for expanded use of the Company’s Monolith Corpectomy System include procedures in the cervical spine (C3-C7 vertebral bodies) to treat a diseased or damaged vertebral body caused by fracture, tumors, osteomyelitis or to support reconstruction following corpe...