Device |
fastener, fixation, biodegradable, soft tissue |
Regulation Description |
Single/multiple component metallic bone fixation appliances and accessories. |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | MAI |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
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? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |