QLQ — Manual Instruments Designed For Use With Total Disc Replacement Devices Class II
Classification Details
- Product Code
- QLQ
- Device Class
- Class II
- Regulation Number
- 888.4515
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250554 | centinel spine | prodisc® L Instruments | April 25, 2025 |
| K242869 | centinel spine | prodisc® L Instruments | December 17, 2024 |
| K241117 | spinal kinetics / orthofix / seaspine | M6-C Single Use, Disposable Instrumentation | June 21, 2024 |
| K231769 | aesculap implants systems | activL® Next Generation Instrumentation | July 13, 2023 |
| K221848 | centinel spine | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | August 19, 2022 |
| K220861 | spinal kinetics | M6-C Artificial Cervical Disc Instruments AS | June 2, 2022 |
| K211757 | nuvasive | Simplify Disc | August 20, 2021 |