Device |
prosthesis, toe, hemi-, phalangeal |
Regulation Description |
Toe joint phalangeal (hemi-toe) polymer prosthesis. |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | KWD |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Joint Arthroplasty Devices
(DHT6A)
|
Submission Type |
510(k)
|
Regulation Number |
888.3730
|
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 |