Manual Instruments Designed For Use With Total Disc Replacement Devices
FDA product code QLQ · Class II (moderate risk) · 21 CFR 888.4515 · Orthopedic
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
9510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262639 | BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional | Spineart SA | 08/14/2026SE |
| K253392 | Synergy Disc InstrumentsQLQ · Traditional | Synergy Spine Solutions, Inc. | 03/27/2026SE |
| K250554 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 04/25/2025SE |
| K242869 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 12/17/2024SE |
| K241117 | M6-C Single Use, Disposable InstrumentationQLQ · Traditional | Spinal Kinetics / Orthofix / Seaspine | 06/21/2024SE |
| K231769 | activL® Next Generation InstrumentationQLQ · Special | Aesculap Implants Systems, LLC | 07/13/2023SE |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional | Centinel Spine, LLC | 08/19/2022SE |
| K220861 | M6-C Artificial Cervical Disc Instruments ASQLQ · Traditional | Spinal Kinetics, LLC | 06/02/2022SE |
| K211757 | Simplify DiscQLQ · Traditional | Nuvasive, Inc. | 08/20/2021SE |