| Device Type ID | 4513 |
| Device Name | Instrument, Bending Or Contouring |
| 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 | HXP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4513 |
| Device | Instrument, Bending Or Contouring |
| Product Code | HXP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 12 |
Device Operates Differently Than Expected | 4 |
Device-Device Incompatibility | 2 |
Mechanical Problem | 1 |
Bent | 1 |
Device Inoperable | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Component Missing | 1 |
| Total Device Problems | 23 |