NuVasive Gains FDA Clearance for COHERE in XLIF

By Julie A. Vetalice

NuVasive received FDA 510(k) clearance for use of the COHERE® Porous PEEK™ implant in XLIF® eXtreme Lateral Interbody Fusion. U.S. commercial launch will occur in 2Q19.

The clearance supports use of the interbody device with autograft and allograft to treat degenerative disc disease, degenerative spondylolisthesis and degenerative scoliosis.

COHERE Porous PEEK is one of two devices from NUVA's Advanced Materials Science™ portfolio undergoing a postmarket U.S. study evaluating advanced spinal implants used in XLIF.

Sources: NuVasive, Inc.; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory