Device |
prosthesis, spinous process spacer/plate |
Definition |
This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process. |
Review Panel |
Orthopedic |
Product Code | NQO |
Premarket Review |
Spinal Devices
(DHT6B)
Spinal Devices
(DHT6B)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|