Definition: Intended To Stabilize Thoracic Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
| Device Type ID | 4681 |
| Device Name | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Physical State | Hollow Cylinder Or Rectangular Box Made Of Metal Or Polymer |
| Technical Method | Acts As A Disc Spacer And Holds Bone Graft. |
| Target Area | Intervertebral Disc Space |
| Regulation Description | Intervertebral Body Fusion Device. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3080 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4681 |
| Device | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Product Code | PHM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intervertebral Body Fusion Device. |
| CFR Regulation Number | 888.3080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALPHATEC SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unintended Movement | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 2 |