Device |
prosthesis, total talus replacement with soft tissue attachment sites, metal |
Definition |
Replaces the native talus |
Physical State |
Solid metallic device with soft tissue attachment sites and not fixed to bones |
Technical Method |
Placed between the distal tibia and calcaneus with soft tissues attached |
Target Area |
Talus |
Review Panel |
Orthopedic |
Product Code | QYQ |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
Submission Type |
HDE - Humanitarian Device Exemption
|
Device Class |
HDE
|
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 |