| Device Type ID | 4527 |
| Device Name | Implant, Fixation Device, Spinal |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| 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) |
| CFR Regulation Number | 888.3060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JDN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4527 |
| Device | Implant, Fixation Device, Spinal |
| Product Code | JDN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| CFR Regulation Number | 888.3060 [🔎] |
| Device Problems | |
|---|---|
Break | 4 |
Mechanical Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Appropriate Term/Code Not Available | 2 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Compatibility Problem | 1 |
Material Integrity Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Crack | 1 |
Rod | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 27 |