FDA product code QAC: Screw Sleeve Bone Fixation Device
QAC is the FDA product code for screw sleeve bone fixation device. It is a Class II device, regulated under 21 CFR 888.3043 and reviewed by the Orthopedic panel. Devices under QAC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
Classification
| Field | Value |
|---|---|
| Device name | Screw Sleeve Bone Fixation Device |
| Device class | Class II |
| Regulation | 21 CFR 888.3043 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for QAC devices
openFDA lists no recalls for product code QAC.
Frequently asked questions
What is FDA product code QAC?
QAC is the FDA product code for screw sleeve bone fixation device. It is a Class II device, regulated under 21 CFR 888.3043 and reviewed by the Orthopedic panel.
What device class is QAC?
Class II, regulation 21 CFR 888.3043. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAC
- Run a recall and safety report across every QAC manufacturer
- Watch product code QAC 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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