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, Gbs Commonwealth Co., Ltd. and Innovasis, Inc..
FDA 510(k) Cleared Intervertebral Fusion Device With Bone Graft, Cervical Devices (Product Code ODP)
About Product Code ODP - Regulatory Context
510(k) Submission Activity
346 total 510(k) submissions under product code ODP since 2008, with 346 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 29 submissions in the last 24 months compared to 46 in the prior period.
FDA Review Time
FDA review times for ODP submissions have been consistent, averaging 132 days recently vs 146 days historically.
ODP devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →