| Device Type ID | 4508 |
| Device Name | Passer, Wire, Orthopedic |
| 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 | HXI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4508 |
| Device | Passer, Wire, Orthopedic |
| Product Code | HXI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SAFEWIRE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 8 |
Break | 5 |
Device Slipped | 4 |
Device Operational Issue | 4 |
Appropriate Term/Code Not Available | 3 |
Difficult To Insert | 3 |
Material Fragmentation | 3 |
Mechanical Problem | 2 |
Use Of Device Problem | 2 |
Fracture | 2 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Degraded | 1 |
Insufficient Information | 1 |
Difficult To Advance | 1 |
Material Deformation | 1 |
| Total Device Problems | 42 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Integra LifeSciences Corp. | II | Jun-28-2016 |