Device Type ID | 4503 |
Device Name | Prosthesis, Tendon, Passive |
Regulation Description | Passive Tendon Prosthesis. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
Submission Type | 510(k) |
CFR Regulation Number | 888.3025 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HXA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 4503 |
Device | Prosthesis, Tendon, Passive |
Product Code | HXA |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Passive Tendon Prosthesis. |
CFR Regulation Number | 888.3025 [🔎] |
Device Problems | |
---|---|
Device Expiration Issue | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 2 |