BAGUERA® C Cervical Disc Surgical Instruments
FDA 510(k) K262639 · Spineart SA
510(k) numberK262639
Submission
- Device name
- BAGUERA® C Cervical Disc Surgical Instruments
- Applicant
- Spineart SA
Plan-Les-Ouates, CH - Received
- July 29, 2026
- Decision date
- August 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4515
- Specialty
- 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.
Other 510(k)s with product code QLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Nuvasive, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261049 | Scala® TLMAX · Traditional | 08/20/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | 07/29/2026SE |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | 05/01/2026SE |
| K254158 | SPINEART Navigation Instrument SystemOLO · Special | 04/09/2026SE |
| K242933 | SPINEART Navigation Instrument SystemOLO · Traditional | 06/18/2025SE |
| K242890 | SPINEART Navigation Instrument SystemOLO · Traditional | 03/07/2025SE |
| K242589 | Scarlet® AL-TMAX · Traditional | 10/23/2024SE |
| K241644 | SPINEART Navigation Instrument SystemOLO · Special | 08/07/2024SE |
| K241321 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | 07/18/2024SE |
| K240699 | SCARLET® AC-TiOVE · Traditional | 05/10/2024SE |
Questions and answers
When was BAGUERA® C Cervical Disc Surgical Instruments cleared by the FDA?
BAGUERA® C Cervical Disc Surgical Instruments (K262639) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 16 days after the submission was received.
What is the product code of K262639?
The FDA product code is QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices, a Class II (moderate risk) device regulated under 21 CFR 888.4515.