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)
- 9
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).