| Device |
absorbable gel for intraoperative use in spine surgery |
| Definition |
This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms. |
| Physical State |
The device is an absorbable, clear, flowable, viscoelastic gel. |
| Technical Method |
The device is applied during lumbar spine surgery to coat and protect the sensory nerves and isolate them from the surrounding tissues and fluid, providing post-surgical reduction in surface exposure of the nerves to irritants and proinflammatory mediators that may cause pain |
| Target Area |
Spine |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QVL |
|---|
| Premarket Review |
Restorative, Repair and Trauma Devices
(DHT6C)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3047
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
