Device |
orthopaedic surgical planning and instrument guides |
Regulation Description |
Single/multiple component metallic bone fixation appliances and accessories. |
Definition |
As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures. |
Physical State |
Software and hardware |
Technical Method |
for pre-surgical planning including transfering, visualizing, measuring, annotating and editing medical data. Patient specific templates that are based on pre-operative plan and are designed to fit a specific patient. These guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments. |
Target Area |
long bones |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | PBF |
Premarket Review |
Restorative, Repair and Trauma Devices
(DHT6C)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
888.3030
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |