| Device Type ID | 4504 |
| Device Name | Probe |
| 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 | HXB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4504 |
| Device | Probe |
| Product Code | HXB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 97 |
Fracture | 26 |
Material Twisted / Bent | 19 |
Bent | 18 |
Crack | 3 |
Naturally Worn | 3 |
Material Deformation | 3 |
Material Fragmentation | 2 |
Mechanical Problem | 2 |
Defective Device | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Output Below Specifications | 1 |
Component Missing | 1 |
Tip | 1 |
| Total Device Problems | 179 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | SpineFrontier, Inc. | II | Jan-03-2014 |
| 2 | Zimmer Trabecular Metal Technology, Inc. | II | Dec-23-2014 |