FDA product code QLR: Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
QLR is the FDA product code for manual instruments designed for use with non-fusion spinous process spacer devices. It is a Class II device, regulated under 21 CFR 888.4520 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QLR, 1 in the last five years. The average 510(k) review took 83 days (median 83); 83 days on average over the last three years. FDA has posted 1 recall for QLR devices, 1 initiated in the last five years.
Definition
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.
Classification
| Field | Value |
|---|---|
| Device name | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices |
| Device class | Class II |
| Regulation | 21 CFR 888.4520 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QLR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 83 |
Compare with all 510(k) review times · Search every QLR clearance
Top QLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Companion Spine France | 1 | 2025-12-16 |
Most recent QLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253118 | Companion Spine France | Companion Spine DIAM Instrumentation | 2025-12-16 | 83 |
Recalls for QLR devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-06-14.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code QLR?
QLR is the FDA product code for manual instruments designed for use with non-fusion spinous process spacer devices. It is a Class II device, regulated under 21 CFR 888.4520 and reviewed by the Orthopedic panel.
What device class is QLR?
Class II, regulation 21 CFR 888.4520. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLR?
Across 1 cleared submissions the average was 83 days from receipt to decision (median 83).
Which companies have the most QLR clearances?
Companion Spine France (1).
Have QLR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-06-14.
Next steps
- Run an FDA pathway report with predicate devices for product code QLR
- Run a recall and safety report across every QLR manufacturer
- Watch product code QLR 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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