Panels › Orthopedic › Product code QLQ · Class 2
Manual Instruments Designed For Use With Total Disc Replacement Devices
Regulation 888.4515
3510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QLQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Centinel Spine, LLC | 4 | 0 |
| Aesculap Implants Systems, LLC | 1 | 0 |
| Nuvasive, Inc. | 1 | 0 |
| Spinal Kinetics, LLC | 1 | 0 |
| Spinal Kinetics / Orthofix / Seaspine | 1 | 0 |
| Spineart SA | 1 | 0 |
| Synergy Spine Solutions, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2026 | K263159 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments Centinel Spine, LLC | QLQ |
| Aug 14, 2026 | K262639 | BAGUERA® C Cervical Disc Surgical Instruments Spineart SA, CH | QLQ |
| Mar 27, 2026 | K253392 | Synergy Disc Instruments Synergy Spine Solutions, Inc. | QLQ |
| Apr 25, 2025 | K250554 | prodisc® L Instruments Centinel Spine, LLC | QLQ |
| Dec 17, 2024 | K242869 | prodisc® L Instruments Centinel Spine, LLC | QLQ |
| Jun 21, 2024 | K241117 | M6-C Single Use, Disposable Instrumentation Spinal Kinetics / Orthofix / Seaspine | QLQ |
| Jul 13, 2023 | K231769 | activL® Next Generation Instrumentation Aesculap Implants Systems, LLC | QLQ |
| Aug 19, 2022 | K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments Centinel Spine, LLC | QLQ |
| Jun 2, 2022 | K220861 | M6-C Artificial Cervical Disc Instruments AS Spinal Kinetics, LLC | QLQ |
| Aug 20, 2021 | K211757 | Simplify Disc Nuvasive, Inc. | QLQ |
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