| Device |
posterior cervical screw placement guide |
| Regulation Description |
Posterior cervical screw system. |
| Definition |
A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans. |
| Physical State |
A posterior cervical screw placement guide, made of polymeric or metallic material, contains a patient-matched surface that is congruent to the mating surface of the posterior elements of the spine. |
| Technical Method |
The device consists of a both a software and hardware component. The software component generates a pre-operative plan based on medical imaging data. The hardware component consists of a patient-matched guide that is positioned onto the posterior elements of the spine. The guide is used to place posterior cervical screws in a pre-operatively desired orientation. |
| Target Area |
Cervical Spine |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QSD |
|---|
| 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 |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
