Device |
cement, bone, pre-formed, modular, polymeric, vertebroplasty |
Regulation Description |
Polymethylmethacrylate (PMMA) bone cement. |
Definition |
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height. |
Physical State |
Interlocking pre-formed polymeric (e.g., PEEK) components sized to the desired vertebral body dimensions |
Technical Method |
Implanted modularly within the vertebral body until desired height is achieved, then encapsulated in PMMA. |
Target Area |
Thoracic or lumbar vertebral bodies |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | OBL |
Premarket Review |
Restorative, Repair and Trauma Devices
(DHT6C)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
888.3027
|
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
|
Recognized Consensus Standards
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |