FDA product code MBS: Filler, Bone Void, Non-Osteoinduction
MBS is the FDA product code for filler, bone void, non-osteoinduction. It is a Class III device, reviewed by the Orthopedic panel. Devices under MBS reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Non-Osteoinduction |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MBS devices
openFDA lists no recalls for product code MBS.
Frequently asked questions
What is FDA product code MBS?
MBS is the FDA product code for filler, bone void, non-osteoinduction. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MBS?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MBS
- Run a recall and safety report across every MBS manufacturer
- Watch product code MBS 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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