Definition: Intended To Be Inserted Between The Vertebral Bodies Into The Disc Space From L3 To S1 To Provide Stabilization And To Help Promote Intervertebral Body Fusion. To Be Used With Bone Graft, For Holding Bone Parts In Alignment While They Heal. Not Inten
| Device Type ID | 4741 |
| Device Name | Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar |
| Physical State | Cobalt Chrome Spheres |
| Technical Method | Inserted Between The Vertebral Bodies In The Disc Space. |
| Target Area | Intervertebral Disc Space From L3 To S1. |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NVR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4741 |
| Device | Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar |
| Product Code | NVR |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 2 |