Device class
Class II
Regulation 888.4515
Total clearances
9
2021-08-20 → 2026-08-14
Definition
What is Manual Instruments Designed For Use With Total Disc Replacement Devices
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Classification details
Medical specialty
Orthopedic
Regulation number
888.4515
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 22865 |
CPT
|
— |
Medium
|
Surgical instrumentation for total disc replacement; standard code for disc prosthesis insertion |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-14 |
K262639 |
Spineart SA
|
BAGUERA® C Cervical Disc Surgical Instruments |
| 2026-03-27 |
K253392 |
Synergy Spine Solutions, Inc.
|
Synergy Disc Instruments |
| 2025-04-25 |
K250554 |
Centinel Spine, LLC
|
prodisc® L Instruments |
| 2024-12-17 |
K242869 |
Centinel Spine, LLC
|
prodisc® L Instruments |
| 2024-06-21 |
K241117 |
Spinal Kinetics / Orthofix / Seaspine
|
M6-C Single Use, Disposable Instrumentation |
| 2023-07-13 |
K231769 |
Aesculap Implants Systems, LLC
|
activL® Next Generation Instrumentation |
| 2022-08-19 |
K221848 |
Centinel Spine, LLC
|
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments |
| 2022-06-02 |
K220861 |
Spinal Kinetics, LLC
|
M6-C Artificial Cervical Disc Instruments AS |
| 2021-08-20 |
K211757 |
Nuvasive, Inc.
|
Simplify Disc |