Manual Instruments Designed For Use With Total Disc Replacement Devices
Manual Instruments Designed For Use With Total Disc Replacement Devices are Class 2 orthopedic surgical instruments intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices in spinal surgery. They require 510(k) clearance and are regulated under 21 CFR 888.4515 within the Orthopedic medical specialty. The product code is QLQ. The devices are not implants and are not flagged as life-sustaining.
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Basic Information
- Product Code
- QLQ
- Device Class
- FDA class 2
- Regulation Number
- 888.4515
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253392 | Synergy Disc Instruments | Mar 27, 2026 | Substantially Equivalent | Synergy Spine Solutions, Inc. |
| K250554 | prodisc® L Instruments | Apr 25, 2025 | Substantially Equivalent | Centinel Spine, LLC |
| K242869 | prodisc® L Instruments | Dec 17, 2024 | Substantially Equivalent | Centinel Spine, LLC |
| K241117 | M6-C Single Use, Disposable Instrumentation | Jun 21, 2024 | Substantially Equivalent | Spinal Kinetics / Orthofix / Seaspine |
| K231769 | activL® Next Generation Instrumentation | Jul 13, 2023 | Substantially Equivalent | Aesculap Implants Systems, LLC |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments | Aug 19, 2022 | Substantially Equivalent | Centinel Spine, LLC |
| K220861 | M6-C Artificial Cervical Disc Instruments AS | Jun 02, 2022 | Substantially Equivalent | Spinal Kinetics, LLC |
| K211757 | Simplify Disc | Aug 20, 2021 | Substantially Equivalent | Nuvasive, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.