Device Type ID | 4622 |
Device Name | Prosthesis, Subtalar, Plug, Polymer |
Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
Submission Type | 510(k) |
CFR Regulation Number | 888.3040 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MJW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4622 |
Device | Prosthesis, Subtalar, Plug, Polymer |
Product Code | MJW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
CFR Regulation Number | 888.3040 [🔎] |
Device Problems | |
---|---|
Device Dislodged Or Dislocated | 1 |
Total Device Problems | 1 |