| Device Type ID | 4598 |
| Device Name | Wire, Surgical |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| 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 | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LRN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4598 |
| Device | Wire, Surgical |
| Product Code | LRN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| CFR Regulation Number | 888.3030 [🔎] |
| Device Problems | |
|---|---|
Break | 89 |
Adverse Event Without Identified Device Or Use Problem | 30 |
Material Fragmentation | 22 |
Device-Device Incompatibility | 8 |
Device Operates Differently Than Expected | 7 |
Material Twisted / Bent | 5 |
Mechanical Jam | 5 |
Bent | 4 |
Appropriate Term/Code Not Available | 3 |
Migration Or Expulsion Of Device | 2 |
Sticking | 2 |
Overheating Of Device | 2 |
Insufficient Information | 2 |
Entrapment Of Device | 2 |
Difficult To Advance | 1 |
Failure To Align | 1 |
Peeled / Delaminated | 1 |
Fracture | 1 |
Migration | 1 |
Wire | 1 |
| Total Device Problems | 189 |