FDA product code QCG: Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions
QCG is the FDA product code for filler, bone void, calcium compound, lower extremity use, use on bone marrow lesions. It is a Not classified device, reviewed by the Orthopedic panel. Devices under QCG reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Intended to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure. These defects may be surgically created from traumatic injury to the bone including bone marrow lesions.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions |
| Device class | Not classified |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for QCG devices
openFDA lists no recalls for product code QCG.
Frequently asked questions
What is FDA product code QCG?
QCG is the FDA product code for filler, bone void, calcium compound, lower extremity use, use on bone marrow lesions. It is a Not classified device, reviewed by the Orthopedic panel.
What device class is QCG?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QCG
- Run a recall and safety report across every QCG manufacturer
- Watch product code QCG 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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