Definition: Vertebral Body Replacement In The Cervical Spine.
| Device Type ID | 4686 |
| Device Name | Spinal Vertebral Body Replacement Device - Cervical |
| Physical State | Metallic Or Polymeric Device (usually Rectangular Or Cylindrical), With Open Central And Lateral Canals For Bone Graft Containment, Providing Rigidity And Structural Support. |
| Technical Method | Provides Structural Support For The Indicated Population. |
| Target Area | Cervical Spine |
| 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) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3060 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4686 |
| Device | Spinal Vertebral Body Replacement Device - Cervical |
| Product Code | PLR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Intervertebral Body Fixation Orthosis. |
| CFR Regulation Number | 888.3060 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Misassembled During Manufacturing / Shipping | 1 |
Packaging Problem | 1 |
| Total Device Problems | 2 |