FDA product code OVO: Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
OVO is the FDA product code for prosthesis, hip, semi-constrained, ceramic-on-metal articulation. It is a Class III device, reviewed by the Orthopedic panel. Devices under OVO reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended as a primary joint replacement prosthesis in total hip arthroplasty.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OVO devices
openFDA lists no recalls for product code OVO.
Frequently asked questions
What is FDA product code OVO?
OVO is the FDA product code for prosthesis, hip, semi-constrained, ceramic-on-metal articulation. It is a Class III device, reviewed by the Orthopedic panel.
What device class is OVO?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OVO
- Run a recall and safety report across every OVO manufacturer
- Watch product code OVO 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.
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