FDA product code QVI: Screw Sleeve Bone Fixation Device, Spine
QVI is the FDA product code for screw sleeve bone fixation device, spine. It is a Class II device, regulated under 21 CFR 888.3043 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under QVI, 2 in the last five years. The average 510(k) review took 89 days (median 89).
Definition
A spinal 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, Spine |
| Device class | Class II |
| Regulation | 21 CFR 888.3043 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QVI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 89 |
Compare with all 510(k) review times · Search every QVI clearance
Top QVI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Woven Orthopedic Technologies | 2 | 2023-10-26 |
Most recent QVI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233223 | Woven Orthopedic Technologies | OGmend® Implant Enhancement System | 2023-10-26 | 28 |
| K223075 | Woven Orthopedic Technologies | Ogmend® Implant Enhancement System | 2023-02-27 | 150 |
Recalls for QVI devices
openFDA lists no recalls for product code QVI.
Frequently asked questions
What is FDA product code QVI?
QVI is the FDA product code for screw sleeve bone fixation device, spine. It is a Class II device, regulated under 21 CFR 888.3043 and reviewed by the Orthopedic panel.
What device class is QVI?
Class II, regulation 21 CFR 888.3043. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVI?
Across 2 cleared submissions the average was 89 days from receipt to decision (median 89).
Which companies have the most QVI clearances?
Woven Orthopedic Technologies (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QVI
- Run a recall and safety report across every QVI manufacturer
- Watch product code QVI 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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