Device class
Class II
Regulation 888.3070
Total clearances
4
2020-10-05 → 2026-02-25
Definition
What is Pedicle Screw Placement Guide
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
Classification details
Medical specialty
Orthopedic
Regulation number
888.3070
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 |
| 22840 |
CPT
|
— |
High
|
Posterior non-segmental instrumentation (e.g., pedicle fixation across one or more vertebral levels that does not constitute a rigid arthrodesis) |
| 22841 |
CPT
|
— |
High
|
Internal spinal fixation by wires, plates, screws, rods or other methods; two to three vertebral segments |
Pulse
Most recent 510(k) clearances