QLQ
8 FDA 510(k) clearances · Product code
70 daysmedian time to decision
178 days90th percentile
8clearances measured
FDA profile
- Official device name
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4515
- Medical specialty
- Orthopedic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Synergy Disc Instruments (K253392) | Synergy Spine Solutions, Inc. | 2026-03-27 |
| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
| prodisc® L Instruments (K242869) | Centinel Spine, LLC | 2024-12-17 |
| M6-C™ Single Use, Disposable Instrumentation (K241117) | Spinal Kinetics / Orthofix / Seaspine | 2024-06-21 |
| activL® Next Generation Instrumentation (K231769) | Aesculap Implants Systems, LLC | 2023-07-13 |
| prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) | Centinel Spine, LLC | 2022-08-19 |
| M6-C Artificial Cervical Disc Instruments AS (K220861) | Spinal Kinetics, LLC | 2022-06-02 |
| Simplify Disc (K211757) | Nuvasive, Inc. | 2021-08-20 |
Track QLQ automatically
Every clearance here is in the API, with alerts when new ones post.