FDA product code OYR: Filler, Bone Void, Recombinant Platelet-Derived Growth Factor
OYR is the FDA product code for filler, bone void, recombinant platelet-derived growth factor. It is a Not classified device, reviewed by the Orthopedic panel. Devices under OYR reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Recombinant Platelet-Derived Growth Factor |
| Device class | Not classified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for OYR devices
openFDA lists no recalls for product code OYR.
Frequently asked questions
What is FDA product code OYR?
OYR is the FDA product code for filler, bone void, recombinant platelet-derived growth factor. It is a Not classified device, reviewed by the Orthopedic panel.
What device class is OYR?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OYR
- Run a recall and safety report across every OYR manufacturer
- Watch product code OYR 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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