QWK · Prosthesis, Posterior Spinal Elements
· Class 3
Overview
| Product Code | QWK |
|---|---|
| Device Name | Prosthesis, Posterior Spinal Elements |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P220002 | TOPS System | Premia Spine, Ltd. | Jun 15, 2023 | APPR |
Top Applicants
- Premia Spine, Ltd. — 1 clearance