Device |
spinal vertebral body replacement device - cervical |
Regulation Description |
Spinal intervertebral body fixation orthosis. |
Definition |
Vertebral body replacement in the cervical spine. |
Physical State |
Metallic or polymeric device (usually rectangular or cylindrical), with open central and lateral canals for bone graft containment, providing rigidity and structural support. |
Technical Method |
Provides structural support for the indicated population. |
Target Area |
Cervical spine |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | PLR |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
Submission Type |
510(k)
|
Regulation Number |
888.3060
|
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
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |