Device |
prosthesis, posterior spinal elements |
Definition |
This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements. |
Physical State |
This device is a posterior prosthesis fixed to the spine by four pedicle screws. |
Technical Method |
This device is designed to provide posterior, non-fusion stabilization following decompression. |
Target Area |
This device is intended to be implanted in the posterior lumbar spine. |
Review Panel |
Orthopedic |
Product Code | QWK |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
Submission Type |
PMA
|
Device Class |
3
|
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 |