| Device Type ID | 4519 |
| Device Name | Cutter, Wire |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| 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) Exempt |
| CFR Regulation Number | 888.4540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HXZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4519 |
| Device | Cutter, Wire |
| Product Code | HXZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 67 |
Material Fragmentation | 10 |
Fracture | 10 |
Device Operates Differently Than Expected | 5 |
Device Inoperable | 4 |
Component Missing | 3 |
Dull, Blunt | 3 |
Mechanical Jam | 2 |
Material Deformation | 2 |
Material Integrity Problem | 2 |
Device Operational Issue | 1 |
Bent | 1 |
Failure To Cut | 1 |
Delamination | 1 |
Appropriate Term/Code Not Available | 1 |
Screw | 1 |
Delivered As Unsterile Product | 1 |
Contamination / Decontamination Problem | 1 |
Component Falling | 1 |
Flaked | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Insufficient Information | 1 |
| Total Device Problems | 121 |