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 |