| Device |
posterior cervical screw system |
| Regulation Description |
Posterior cervical screw system. |
| Definition |
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. |
| Physical State |
Metallic plates, longitudinal members (e.g., rods) and other device-specific accessories. |
| Technical Method |
Use of screws and longitudinal members (e.g., rods) to stabilization spinal segments for fusion. |
| Target Area |
Posterior cervical spine |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | NKG |
|---|
| Premarket Review |
Spinal Devices
(DHT6B)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3075
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
