QLQ
- Product code
- QLQ
- Device name
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.4515
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262639 | 2026-08-14 | Spineart SA | BAGUERA® C Cervical Disc Surgical Instruments | |
| K253392 | 2026-03-27 | Synergy Spine Solutions, Inc. | Synergy Disc Instruments | |
| K250554 | 2025-04-25 | Centinel Spine, LLC | prodisc® L Instruments | |
| K242869 | 2024-12-17 | Centinel Spine, LLC | prodisc® L Instruments | |
| K241117 | 2024-06-21 | Spinal Kinetics / Orthofix / Seaspine | M6-C Single Use, Disposable Instrumentation |
Official FDA classification page: QLQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).