Device |
absorbable metallic bone fixation fastener |
Definition |
An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved. |
Physical State |
Smooth or threaded absorbable metallic bone fixation fastener, such as bone screws, pins and k-wires |
Technical Method |
Connect bones or bone fragments providing stability for osteosynthesis. |
Target Area |
Bone (fractured bone and osteotomy) |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | QJD |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
888.3041
|
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? |
Yes
|
Third Party Review |
Not Third Party Eligible |