Device |
ankle fusion cage |
Regulation Description |
Intramedullary fixation rod. |
Definition |
Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use. |
Physical State |
Cylinder, spherical or rectangular box made of metal with open space throughout. |
Technical Method |
Acts as a structural spacer and is used as an accessory to a tibiotalocalcaneal IM rod. |
Target Area |
Ankle |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | SAI |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
Submission Type |
510(k)
|
Regulation Number |
888.3020
|
Device Class |
2
|
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 |