FDA product code QLQ: Manual Instruments Designed For Use With Total Disc Replacement Devices
QLQ is the FDA product code for manual instruments designed for use with total disc replacement devices. It is a Class II device, regulated under 21 CFR 888.4515 and reviewed by the Orthopedic panel. FDA has cleared 9 510(k) submissions under QLQ, 8 in the last five years, from 7 different applicants. The average 510(k) review took 70 days (median 59); 77 days on average over the last three years.
Definition
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Classification
| Field | Value |
|---|---|
| Device name | Manual Instruments Designed For Use With Total Disc Replacement Devices |
| Device class | Class II |
| Regulation | 21 CFR 888.4515 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for QLQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 74 |
| 2022 | 2 | 63 |
| 2023 | 1 | 27 |
| 2024 | 2 | 74 |
| 2025 | 1 | 59 |
| 2026 | 2 | 97 |
Compare with all 510(k) review times · Search every QLQ clearance
Top QLQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centinel Spine, LLC | 3 | 2025-04-25 |
| Spineart SA | 1 | 2026-08-14 |
| Synergy Spine Solutions, Inc. | 1 | 2026-03-27 |
| Spinal Kinetics / Orthofix / Seaspine | 1 | 2024-06-21 |
| Aesculap Implants Systems, LLC | 1 | 2023-07-13 |
2 more applicants have QLQ clearances. See the full list in Caduvo.
Most recent QLQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262639 | Spineart SA | BAGUERA® C Cervical Disc Surgical Instruments | 2026-08-14 | 16 |
| K253392 | Synergy Spine Solutions, Inc. | Synergy Disc Instruments | 2026-03-27 | 178 |
| K250554 | Centinel Spine, LLC | prodisc® L Instruments | 2025-04-25 | 59 |
| K242869 | Centinel Spine, LLC | prodisc® L Instruments | 2024-12-17 | 88 |
| K241117 | Spinal Kinetics / Orthofix / Seaspine | M6-C Single Use, Disposable Instrumentation | 2024-06-21 | 59 |
Recalls for QLQ devices
openFDA lists no recalls for product code QLQ.
Frequently asked questions
What is FDA product code QLQ?
QLQ is the FDA product code for manual instruments designed for use with total disc replacement devices. It is a Class II device, regulated under 21 CFR 888.4515 and reviewed by the Orthopedic panel.
What device class is QLQ?
Class II, regulation 21 CFR 888.4515. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLQ?
Across 9 cleared submissions the average was 70 days from receipt to decision (median 59).
Which companies have the most QLQ clearances?
Centinel Spine, LLC (3); Spineart SA (1); Synergy Spine Solutions, Inc. (1); Spinal Kinetics / Orthofix / Seaspine (1); Aesculap Implants Systems, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QLQ
- Run a recall and safety report across every QLQ manufacturer
- Watch product code QLQ 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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