FDA product code NVC: Bone, Heterograft
NVC is the FDA product code for bone, heterograft. It is a Class III device, regulated under 21 CFR 888.3015 and reviewed by the Orthopedic panel. Devices under NVC reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Bone, Heterograft |
| Device class | Class III |
| Regulation | 21 CFR 888.3015 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NVC devices
openFDA lists no recalls for product code NVC.
Frequently asked questions
What is FDA product code NVC?
NVC is the FDA product code for bone, heterograft. It is a Class III device, regulated under 21 CFR 888.3015 and reviewed by the Orthopedic panel.
What device class is NVC?
Class III, regulation 21 CFR 888.3015. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NVC
- Run a recall and safety report across every NVC manufacturer
- Watch product code NVC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.