NVC — Bone, Heterograft Class III
FDA product code NVC covers "Bone, Heterograft", a Class III medical device regulated under 21 CFR 888.3015. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- NVC
- Device Class
- Class III
- Regulation Number
- 888.3015
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN.