SGK · Prosthesis, Spinous Process Tension Band Implant
· Class 3
Overview
| Product Code | SGK |
|---|---|
| Device Name | Prosthesis, Spinous Process Tension Band Implant |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P220031 | LimiFlex Dynamic Sagittal Tether | Empirical Spine, Inc. | Feb 12, 2026 | APPR |
Top Applicants
- Empirical Spine, Inc. — 1 clearance
