| Device Type ID | 4557 |
| Device Name | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| 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 | KTW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4557 |
| Device | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Product Code | KTW |
| 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 | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 41 |
Break | 30 |
Migration Or Expulsion Of Device | 12 |
Fitting Problem | 7 |
Device Operates Differently Than Expected | 5 |
Appropriate Term/Code Not Available | 3 |
Unintended Movement | 3 |
Sticking | 2 |
Device-Device Incompatibility | 1 |
Mechanical Jam | 1 |
Failure To Align | 1 |
Dull, Blunt | 1 |
Device Dislodged Or Dislocated | 1 |
Material Twisted / Bent | 1 |
Bent | 1 |
| Total Device Problems | 110 |