FDA Product Code ODP: Intervertebral Fusion Device With Bone Graft, Cervical
FDA product code ODP covers cervical intervertebral fusion devices with bone graft.
These implants are placed between adjacent cervical vertebrae to restore disc height, maintain cervical alignment, and facilitate interbody fusion of the unstable spinal segment. They are used in anterior cervical discectomy and fusion procedures for the treatment of herniated discs, degenerative disc disease, and cervical myelopathy.
ODP devices are Class II medical devices, regulated under 21 CFR 888.3080 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Vy Spine, LLC, Innovasis, Inc. and Alphatec Spine, Inc..
List of Intervertebral Fusion Device With Bone Graft, Cervical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Intervertebral Fusion Device With Bone Graft, Cervical devices (product code ODP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →