Device Type ID | 1105 |
Device Name | Wire, Fixation, Intraosseous |
Regulation Description | Intraosseous Fixation Screw Or Wire. |
Regulation Medical Specialty | Dental |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | 510(k) |
CFR Regulation Number | 872.4880 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DZK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1105 |
Device | Wire, Fixation, Intraosseous |
Product Code | DZK |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Intraosseous Fixation Screw Or Wire. |
CFR Regulation Number | 872.4880 [🔎] |
Device Problems | |
---|---|
Break | 1 |
Insufficient Information | 1 |
Total Device Problems | 2 |