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 |