| Device |
spinous process plate |
| Regulation Description |
Spinal interlaminal fixation orthosis. |
| Definition |
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use. |
| Physical State |
Plates with teeth/spikes and crossbar/tray/bumper that connects and locks plates together, metallic, metallic and polymer combination |
| Technical Method |
Placed between two spinous processes to immobilize the segment, provide supplemental stabilization, and to facilitate fusion at the treated level |
| Target Area |
Non-cervical spine (T1-S1) |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | PEK |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3050
|
|---|
| 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 Standard
|
| Third Party Review |
Not Third Party Eligible |
