M6-C Single Use, Disposable Instrumentation
FDA 510(k) K241117 · Spinal Kinetics / Orthofix / Seaspine
510(k) numberK241117
Submission
- Device name
- M6-C Single Use, Disposable Instrumentation
- Applicant
- Spinal Kinetics / Orthofix / Seaspine
Sunnyvale, CA, US - Received
- April 23, 2024
- Decision date
- June 21, 2024
- 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 |
|---|---|---|---|
| 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 |
| 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 |
Questions and answers
When was M6-C Single Use, Disposable Instrumentation cleared by the FDA?
M6-C Single Use, Disposable Instrumentation (K241117) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 59 days after the submission was received.
What is the product code of K241117?
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.